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Regulative Decree n.º 61/94 of October 12 : Anti-Drug Legislation

Following the publication of Decree-Law No. 15/93, of 22 January, that revised the anti-drug legislation, it is now question of laying down rules for the application of the provisions of Article 2, paragraphs 4 and 5, Articles 4 to 20 and Articles 65 to 68 of that Decree-Law.

The control of precursors and other chemical products that are instrumental in producing drugs - substances listed in Tables V and VI appended to that Decree-Law - but may be diverted towards the illegal market, presents some difficulties to the extent that a certain number of such substances is currently used in commercial, industrial and social activities.

Such control must be carried out both in conformity with the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances and with reference to Community law subscribed by Portugal; it will be possible only if it results from concerted and efficient action of the different departments and entities with powers in this field.

Indeed, with respect to narcotic drugs and psychotropic substances - listed in Tables I to IV appended to that Decree-Law - the legislation presently in force requires only few adaptations resulting mainly from the practical application of Regulative Decree No. 71/84, of 7 September, and also from the wish to bring more efficiency to control measures; however, with respect to precursors and other substances used in the production of drugs, new rules must be provided for that take into account international treaty law and Community law.

This opportunity was seized to transpose into the domestic legal system Council Directive No. 92/109/EEC, of 14 December 1992, on the production and marketing of certain substances used in the illicit production of narcotic drugs and psychotropic substances, amended by Commission Directive No. 93/46/EEC, of 22 June 1993.

At the same time, account is being taken of Community regulations concerning the control of such substances with respect to the trade between the Community and third countries, in particular Council Regulation (EEC) No. 3677/90, of 13 December 1990, amended by Council Regulation (EEC) No. 900/92, of 31 March 1992, and Commission Regulation (EEC) No. 3769/92, of 21 December 1992.

Aware of the fact that both international and Community requirements, in particular in the field of controlling the illicit drugs' market, are more and more important and pressing, this act fixes the specific role of each public entity, without prejudice to the necessary global coordination.

For the same reason, the solutions adopted take care in a harmonious and global way of the procedures that should be followed by other entities called upon to intervene in the application of this act.

The Ordem dos Médicos , the Ordem dos Médicos Veterinários and the Ordem dos Farmacêuticos were heard.


The self-governing bodies of the Autonomous Regions of the Azores and Madeira were heard.

Thus:In conformity with the provisions of Article 76, paragraph 2, of Decree-Law No. 15/93, of 22 January, and under the terms of Article 202, paragraph c), of the Constitution, the Government decides as follows:



CHAPTER I

General provisions

Article 1

Purpose and definitions

1. This act lays down the rules concerning the control of the licit market of narcotic drugs, psychotropic substances, precursors and other chemical products that may be used for the preparation of drugs listed in Tables I to VI appended to Decree-Law No. 15/93, of 22 January, hereinafter mentioned by the word "Tables".

2. For the purposes of this act and without prejudice neither to the definitions incorporated in the conventions concerning narcotic drugs, psychotropic substances and precursors that were ratified by Portugal, nor to the Regulations of the European Community, the following shall be interpreted to mean:

a) Production: obtaining narcotic drugs, psychotropic substances or drug precursors, from natural organisms, either by way of collecting or by way of extracting;

b) Manufacture: operations, including purification and transformation of a given product into a different product, by way of which narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, can be obtained;



c) Manipulation: operations by way of which narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, can be transformed through physical or chemical procedures;

d) Import: material introduction into the national territory of narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, coming from non-Community countries;

e) Export: material flow out of the national territory of narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, towards non-Community countries; re-exports shall be taken for exports;

f) Transit: passage through, or transfer from vessel to vessel within the national territory, of narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, coming from or going to non-Community countries;

g) Introduction: material introduction into the national territory of narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, coming from another Community country;

h) Dispatch: material flow out of the national territory of narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, towards another Community country;

i) Wholesale trade: purchase of narcotic drugs, psychotropic substances, precursors and other chemical products that may be diverted for the purpose of obtaining drugs, in the purchaser's name and on his own account, followed by resale to other tradesmen, wholesalers, retail dealers, transformers, professional users or big users;

j) Classified substance: any substance listed in Tables V and VI, save Chloridric acid salts and Sulphuric acid salts, including any mixture containing such substances, except for medicinal drugs and other preparations from which it is not easy to use or recuperate such substances;

l) Marketing: offer to third parties, free of charge or against a price, of any classified substances produced or introduced in the Community;

m) Operator: physical or legal person who is engaged in manufacturing, transforming, trading in or distributing classified substances in the Community, or other activities with the same aim.

Article 2

Scope

1. The cultivation, production, manufacture, employment, trade in, distribution, import, export, introduction, dispatch, transit, possession regardless of title, as well as the use of any plants, substances and preparations listed in Tables I to IV shall be made subject to requirements, authorizations and supervision, as provided for in Decree-Law No. 15/93, of 22 January, and in this act.

2. The production, manufacture, import, export, marketing, transit and possession regardless of title of any substances listed in Tables V and VI shall be made subject to licences, authorizations, statistic control and supervision, as provided for in Decree-Law No. 15/93, of 22 January, and in this act.

Article 3

Technical rules and concepts

The technical rules and concepts mentioned in this act shall be interpreted in consonance with the conventions concerning narcotic drugs and psychotropic substances that were ratified by Portugal.



Article 4

General duty to inform

Within the delay that will have been fixed for that purpose, all entities that are authorized to perform the activities mentioned in Article 2 shall disclose any information that is legally requested from them by any of the entities that have supervisory powers.

CHAPTER II

Authorizations, requirements and control

concerning Tables I to IV



Section I

Authorizations

Article 5

General rules



1. The Chairman of the board of the National Institute of Pharmacy and Medicinal Drugs (INFARMED) shall be empowered to grant, revoke and suspend authorizations to perform any of the activities mentioned in Article 2, paragraph 1; he may delegate such powers on any of the other members of the board, or on any of the members of the staff with managerial functions.

2. Authorizations shall be granted only where the country's needs so require and subject to the use of the substances and preparations being limited to medical, veterinary, scientific, analytical or didactic purposes, save the exceptions provided for in the conventions mentioned in Article 3.

3. For the purposes of Article 4, paragraph 1, of Decree-Law No. 15/93, the provisions of paragraphs 4 and 5 of that Article shall apply to requests submitted for the first time by entities that are not yet authorized to carry out activities regulated in this act.



Article 6

Requests for an authorization and

requests to hold on to an authorization

1. All requests for an authorization, as well as requests to hold on to an authorization to carry out any of the activities regulated in Article 2, paragraph 1, shall be addressed to the chairman of the INFARMED; such requests shall include the identification of the physical or legal person that submits the request, his, her or its identity card, as well as any other particulars provided for in other provisions.

2. Requests made under Article 5, paragraph 3, shall also include the identification of the persons responsible both for preparing and keeping up to date the records, and carrying out such other duties as may be imposed upon them; such persons must declare that they are ready and willing to assume such responsibilities.

3. A separate request must be submitted with respect to each branch or depot.

4. Requests must be accompanied by an extract of the criminal record concerning the requesting parties, the persons mentioned in paragraph 2 and, in the case of a legal person, the persons who are entitled to act on its behalf.

5. Requests to hold on to an authorization must be accompanied either by documents giving evidence of the replacement of the bearer, or the change in the name of the firm, or the removal of its premises, or by a death certificate, as the case may be.



Article 7

Subjective requirements

1. The aptitude of the requesting party shall be measured against his, her or its criminal record and record of regulatory offences, as well as the information obtained by The Ministry of Justice's Office for the Fight against Drugs (GCDMJ); in obtaining that information, the GCDMJ shall respect the rights, liberties and safeguards of the citizens and be guided exclusively by the public interest with respect both to health and the fight against traffic in narcotic drugs and psychotropic substances.

2. The requesting party shall, under the terms of the general law, enjoy the right of access to the information mentioned in the preceding paragraph; it may challenge such information and dispute the way in which it was obtained.

3. With respect to requests submitted by civil or military State hospitals, there shall be no requirements, neither to the effect that the GCDMJ be heard, nor to the effect that criminal records and records of regulatory offences be produced.



Article 8

Decisions granting or refusing authorizations

and decisions granting leave to hold on to an authorization

1. Authorizations shall not be transmissible and may not be transferred to or used by any party other than their bearer, on any basis whatsoever.

2. Authorizations granted in general terms to physical or legal persons for the purpose of carrying out any of the activities mentioned in Article 2, paragraph 1, shall remain valid for a period of one year; where the INFARMED remains silent on that subject up to 90 days before the end of that period, authorizations shall be deemed to be renewed for an equal period of time.

3. Each specific authorization shall be valid for the period of time specified therein. That period shall not be longer than one year.

4. Decisions granting authorizations that are taken upon requests made under Article 5, paragraph 3, shall be published in the Diário da República , series No. 2, and the period of validity shall run as from the date of publication. Such decisions shall fix the special requirements that are imposed upon the bearer.

5. Decisions refusing authorizations, that are taken by the chairman of the board of the INFARMED shall be open to an appeal.



Article 9

Lapse to authorizations

1. Requests to hold on to an authorization, in the cases provided for in Article 8, paragraph 1, of Decree-Law No. 15/93, must be submitted at the latest 60 days after the date of the change in the name of the firm, the death or the replacement of the bearer or legal representative of the enterprise or authorized entity. Requests submitted after that time-limit shall be rejected.

2. The publication of any Order that lays a ban on the cultivation of certain plants or shrubs, or the manufacture, the preparation or the trade in certain substances or preparations, under the terms of Article 5, paragraphs 4 and 5, of Decree-Law No. 15/93, shall automatically entail the lapse of any authorizations granted in order to carry out such activities.

3. The provisions of Article 10 of Decree-Law No. 15/93, modified as appropriate, shall apply to cases of lapse of authorizations.

Article 10

Authorizations cancelled or suspended

1. Authorizations shall be cancelled as soon as the requirements listed in Article 5, paragraph 2, Article 7 and Article 8, paragraph 1, no longer are met. This shall be without prejudice to the imposition of any applicable regulatory sanctions.

2. All decisions that cancel or suspend an authorization shall be published in the Diário da República, series No. 2.

3. Decisions, as mentioned in this Article, taken by the chairman of the board of the INFARMED shall be open to an appeal.



Article 11

Consequences of cancelation of authorizations

Requests as mentioned in Article 10 of Decree-Law No. 15/93, where the return of the existing stock of substances and preparations to the entities who had provided them, or the transfer of such stock to other entities, authorized businesses or pharmacies, is requested, must be accompanied by a declaration made by such entities, businesses or pharmacies stating their agreement in case the request is granted, as well as a detailed list of such substances and preparations.

Article 12

Communication of authorizations

1. The INFARMED shall inform the High Commissioner for the VIDA project and the GCDMJ of any authorization granted for carrying out any of the activities mentioned in Article 2, paragraph 1, as well as any decision that prolongs the validity of, or suspends or cancels an authorization.

2. The GCDMJ must inform the Polícia Judiciária , the Polícia de Segurança Pública , the Guarda Nacional Republicana and the Directorate General of Customs (DGA) of any authorizations granted; at the same time, it must indicate which of these authorities shall be especially responsible for the control of the operations and on which terms.

Section II

Cultivation, production and manufacture

Article 13

Cultivation

1. Whoever seeks to obtain an authorizations to cultivate any of the vegetable species listed in Tables I or II, for medical or veterinary purposes or purposes of scientific investigation, must request such an authorization from the INFARMED.

2. Requests must include, other than the elements mentioned in Article 6, the following:

a) Full identification of the cultivator or cultivators, where different from that of the requesting party;

b) Location and area of the plot to be cultivated;

c) Quantity and name of the vegetable species to be sowed or planted;

d) Probable quantity of product to be collected, how and where it is going to be used;

e) Place where the product is to be stored and security conditions therein while awaiting delivery to the official entity entrusted with collecting it.

3. Where the cultivation of vegetable species is authorized and such cultivation requires special controls under the provisions of conventions ratified by Portugal, the entity or entities that shall carry out such controls shall be identified. This shall be done in accordance with the law. All the other rules provided in such conventions shall be respected.



Article 14

Surplus

1. Any surplus of crop of no more than 10% of the authorized quantity may be accepted if the INFARMED is informed within 15 days from the date of calculation of the surplus.

2. Any surplus shall be set off against quantities scheduled to be produced in the following year.

3. The INFARMED shall order the seizure of any non authorized surplus and, unless used for any lawful purposes, shall dispose of it in accordance with the provisions of Article 62 of Decree-Law No. 15/93. If necessary, it may request, directly or through the GCDMJ, the assistance of the police authorities.

4. Where a ban on cultivation, as mentioned in Article 5, paragraphs 4 and 5, of Decree-Law No. 15/93, entails the destruction of previously authorized existing cultivations, the State, in accordance with the law, shall pay compensation to the entities who carried out the cultivation, for the expenses incurred.

Article 15

Extraction and manufacture

1. Whoever for the first time seeks to obtain an authorization to extract alkaloids from any vegetable species listed in Tables I-A, I-B or I-C, or to manufacture alkaloids as a product of synthesis, in a given year, for medical or veterinary purposes or purposes of scientific investigation, must request such an authorization from the INFARMED by 31 October of the year before.

2. Whoever wishes to extract, transform or manufacture any of the substances or preparations listed in Tables I to IV, must proceed in the same way and within the same time-limit, without prejudice to the provisions of the following paragraph.

3. Authorizations to manufacture any of the substances listed in Table II-A may only be granted for purposes of scientific investigation.

4. Requests must include, other than the elements mentioned in Article 6, the following:

a) Graphic description of the site of manufacture and/or storage of substances and/or preparations, and its security conditions;

b) Identification and professional qualification of the person responsible in technical terms;

c) Nature and quantity of the raw materials necessary for manufacturing;

d) Substances and preparations that are to be manufactured, quantities to be manufactured, their destination and processes of extraction.

5. Authorizations to manufacture shall also valid for the acquisition and storage of raw materials, as well as the sale of the products obtained subject to the buyer being an authorized entity.

6. The use by the industry of any substances listed in Tables I, II-B or II-C for purposes other than medical or veterinary purposes or purposes of scientific investigation, may only be authorized if the requesting party gives evidence that it can master the appropriate technical means of transformation or any other means preventing (a) any improper use of the substances, (b) bringing about harmful effects and (c) the practical possibility of recovery of the substances.

7. Decisions granting authorizations shall fix such requirements as are necessary in order to allow the INFARMED to prevent narcotic drugs from piling up beyond the needs of the market or those relating to the normal operation of the requesting party.

Article 16

Quotas for the manufacture of substances

1. Bearing in mind any international commitments entered and in accordance with the rules laid down in conventions, the INFARMED shall in November of each year fix the quantities of substances listed in Tables I or II but not in Table II-A that may be manufactured or offered for sale by the authorized entities during the year following.

2. The quantities fixed may be raised during the year to which the authorization respects; when special circumstances so require, the INFARMED is entitled at any time to impose limits to the manufacture of certain substances and preparations.

3. Quotas fixed under the terms of paragraph 1, as well as any changes thereto, shall be published in the Diário da República, series No. 2.

4. The provisions of Article 14, paragraph 4, apply to any ban on manufacturing.



Section III

Wholesale trade

Article 17

Authorizations for wholesale trade



1. Whoever seeks to obtain an authorization for wholesale trade in any substances listed in Tables I, II or IV but not in Table II-A must request such an authorization from the INFARMED.

2. Requests must include, other than the elements mentioned in Article 6, the following:

a) Location of the establishment, depot or storehouse where trade is to be engaged;

b) Places for the reception, storage, dispatch and delivery of products;

c) Security measures already adopted or planned to be adopted;

d) Substances and preparations intended to be traded.

3. Decisions granting authorizations shall fix such requirements as are necessary in order to allow the INFARMED to prevent narcotic drugs and psychotropic substances from piling up beyond the needs of the market or those relating to the normal operation of the requesting party.



Article 18

Sale or transfer of substances and preparations

1. Without prejudice to the provisions of the following paragraph, the sale or transfer of any substances and preparations listed in Tables I to IV but not in Table II-A, to civil or military State hospitals, pharmacies or other lawfully authorized entities, may only be done by way of a written requisition, duly signed and authenticated by the person responsible; requisitions shall either be written on a standard form extracted from a book approved by the INFARMED, or produced by way of a computerised document of equivalent value.

2. The sale or transfer of any preparations listed in Table III by enterprises authorized to deal in wholesale trade, to civil or military State hospitals, or to pharmacies, shall not be subject to the formalities mentioned in the preceding paragraph.

3. Deliveries by manufacturers to medical doctors and veterinary surgeons, of samples of any preparations listed in Tables III and IV, may only be done by way of a requisition, under terms to be fixed by the INFARMED.

4. Deliveries of samples of any substances listed in Tables I and II shall be prohibited.



Article 19

Requisitions

1. Documents as mentioned in Article 18, paragraph 1, shall be drawn up in duplicate; the party that issues the requisition shall keep the original and the supplier shall keep the copy.

2. Each requisition shall be used for one kind of substance only.

Article 20

Delivery procedure

1. Deliveries of substances and preparations listed in Tables I to IV but not in Table II-A may only be made according to one of the following procedures:

a) Personally, to the bearer of the authorization, the pharmacist, or one or the other's representative, or to persons responsible as mentioned in Article 18, paragraph 1; the name of the recipient as well as the number and date of issue of his identity card or any other reliable identification document, shall be inscribed on the margin of the requisition or requisitions;

b) Through a transport agency or private courier.

2. Transport of any substances listed in Table I in quantities in excess of 1 kg. shall not be carried out without prior written notification from the supplier to the nearest police authority.

3. Notifications as mentioned in the preceding paragraph shall mention the names of the supplier and the consignee, the means of transport used, the date and hour of the transport, as well as the nature and quantity of the substances to be transported.

4. Notifications shall be drawn up in triplicate, three days in advance of the event; the police authority shall keep one copy, forward another copy to the authority with jurisdiction over the area of destination and stamp the last copy; the latter copy shall accompany the merchandise and be returned by the consignee to the supplier.

5. The supplier must keep the requisition in his files for a period of three years; where the merchandise is delivered through a transport agency or private courier, the supplier must keep the acknowledgement of receipt in his files for a period of three years; the party that issues the requisition must keep the copy thereof in his files for a period of three years.



Article 21

Supply for specific purposes

1. The INFARMED may authorize the supply of any substances and preparations listed in Tables I-A, II-B, II-C and IV:

a) To public and private organizations of recognized reputation, for investigation or teaching purposes; the supply to such organizations of any substances and preparations listed in the other Tables may also be authorized;

b) To merchant ships, aircraft and other means of international public transport, for purposes of first aid, under the terms of Article 14 of Decree-Law No. 15/93; the request must be made by the vessel's doctor or, where the vessel does not have a doctor, by the medical doctor of the respective enterprise; it must mention the ship's or aircraft's name and number, as well as the place of its registration, or other particulars that adequately identify the vessel; the applicable customs' rules shall be respected.

2. The request shall identify the person responsible for the storage and safekeeping of the substances and preparations; that person must declare that he is ready and willing to assume such responsibilities; the request must also describe the security arrangements.

3. The quantity of substances and preparations stored shall not be in excess of what is indispensable for pursuing normally the authorized aims.

4. Provided that the general requirements are respected, the supply of substances listed in Table I-A to the Department for the Prevention and Treatment of Drug-dependents (SPTT) for purposes of treatment with alternative narcotic drugs, may be authorized.

5. Treatments with alternative narcotic drugs may only be administered subject to authorization and under the control of the SPTT.



Section IV

Import, export, transit, introduction and dispatch

Article 22

Import, export and trade

1. Import, export, transit, introduction and dispatch of any substances or preparations listed in Tables I, II and IV may be carried out only by entities and enterprises authorized to cultivate, manufacture, manipulate or engage in wholesale trade in such substances or preparations, or use them for teaching or therapeutic purposes or purposes of scientific investigation.

2. Authorizations shall be granted for one operation at a time only, but may be used in respect of smaller quantities than those authorized.

Article 23

Requests for import or export

1. Requests for an authorization to import, export, transit, introduction or dispatch of any substances or preparations listed in Tables I, II and IV, must include, other than the elements mentioned in Article 6, the following:

a) Name and, where appropriate, common international designation of the substance or preparation;

b) Quantities to be imported, exported, introduced or dispatched;

c) Identification of the exporter or sender in cases of import or introduction and identification of consignee in cases of export or dispatch;

d) Time of import, export, transit, introduction or dispatch, means of dispatch or transport used and indication of the customs house at point of entry or exit;

e) Where alkaloids present are not pure alkaloids, or where the substances or preparations are conjunct medicinal drugs, the percentage of alkaloids components in the substances or preparations.

2. Requests for an authorization to export or dispatch must also include an authorization to import or introduce issued by the authorities of the country of destination of the merchandise.



Article 24

Notification to the DGA

Once the import or export of any substances or preparations listed in Tables I, II and IV is authorized, the INFARMED shall so notify the DGA, without prejudice to the provisions of Article 12.

Article 25

Prohibited exports and imports

1. Export or dispatch, by way of a remittance addressed to a bank or a post office box for the attention of a consignee other than the consignee who is indicated in the authorization, of any substances or preparations listed in Tables I, II and IV, shall be prohibited.

2. Export by way of a remittance addressed to a customs' warehouse shall also be prohibited, save where the government of the importing country certifies in the import authorization its agreement to that effect.

3. In cases of remittance to a customs' warehouse under the terms of the preceding paragraph, the export authorization shall mention that circumstance.

4. Whoever exports or dispatches substances or preparations mentioned in paragraph 1, must proceed in such a way as to make it impossible to open the parcel without damaging the seals.



Article 26

Request for transit authorizations

1. Requests for an authorization for the transit through the Portuguese territory of any substances or preparations listed in Tables I and II, but not listed in Tables II-A and IV, must include, other than the elements mentioned in Article 6, the export authorization issued by the authorities of the country of origin of the merchandise.

2. Any request to change the destination of the merchandise from the country initially scheduled to another country, should it be granted, shall be subject to the requirements concerning exports.



Section V

Prescriptions, supply upon prescription and control

Article 27

Prescriptions

1. Substances and preparations listed in Tables I and II may be supplied to the public for treatment purposes only upon presentation of a medical or veterinary prescription containing the elements mentioned in the following paragraphs.

2. The INFARMED, in co-operation with the Directorate General for Health and the regional health administrations (ARS), after having heard the Ordem dos Médicos, the Ordem dos Médicos Veterinários, the Ordem dos Farmacêuticos and the National Association of Pharmacies, shall adopt a standard model book from which forms for prescriptions are extracted and where counterfoils are kept.

3. Prescriptions shall be numbered and include the references mentioned in Article 15, paragraph 3, of Decree-Law No. 15/93; prescriptions may be adapted with a view to their being processed by means of a computer.

4. Prescriptions shall be drawn up in triplicate; the counterfoil shall be kept for a period of three years in the archives, easily accessible as they must be, of the medical doctor or the veterinary surgeon as appropriate; the first copy shall be forwarded, as appropriate, either to the competent ARS or to the Ordem dos Médicos Veterinários; another copy shall be kept at the pharmacy; the last copy shall be forwarded to the INFARMED.

Article 28

Supply upon prescription

1. Pharmacists who supply upon a special prescription concerning narcotic drugs or psychotropic substances must (a) check the identity of the buyer, (b) inscribe on the margin of the prescription the latter's name, the number and date of issue of either his identity card, his driving license, or, in case of an alien, his passport, as well as the date of the delivery, and (c) sign in a legible way.

2. Pharmacists may identify buyers on the face of other documents provided that the latter include a photograph; in such cases the pharmacist must take down the buyer's signature and, if the latter cannot or is not able to sign, he must declare that in writing.

3. Pharmacists shall refuse to supply upon prescription medicinal drugs containing narcotic drugs or psychotropic substances:

a) Where the prescriptions are not drawn up in the model form approved by the INFARMED;

b) Where he has well founded doubts about the authenticity of the prescription;

c) Where more than ten days have passed since the date of the prescription;

d) Where the articles prescribed were already supplied.

4. In the case mentioned in sub-paragraph (b) above, the pharmacist shall, if possible, at the buyer's expense, contact the medical doctor or the veterinary surgeon who wrote out the prescription.

5. Pharmacies shall keep in their records for a period of three years a copy of all the prescriptions in chronological order according to the date of supply.

6. Pharmacists who supply upon a prescription under the terms of Article 19, paragraph 3, of Decree-Law No. 15/93, shall take down, on the back of the copy of the prescription that is kept by him, further to other indications, the signature of the person who claims to be in charge of the under-age person or of his education or supervision; if that person cannot or is not able to sign, the pharmacist shall proceed as is provided in paragraph 2.

Article 29

State and private health services

1. In both the State's and private health services, responsibility for the control of substances and preparations listed in Tables I and II shall belong to the pharmacy committees and therapeutic committees or, where such committees do not exist, to the clinical directors and pharmaceutical directors; persons on whom such responsibilities fall shall communicate to the INFARMED, under terms and periodicity to be agreed upon, such data and information as is considered indispensable.

2. Without prejudice to the provisions of the preceding paragraph, the State's and the private health services shall forward to the INFARMED every three months a list of the narcotic drugs used for purposes of medical treatment; that list shall be drawn up according to a model approved by the INFARMED, either in manual or computer-based form.

3. The registers mentioned in Section VI shall be prepared by the services mentioned in the preceding paragraph.



Article 30

Distribution and control of prescriptions

1. The model book of prescriptions shall remain an exclusive product of the Imprensa Nacional-Casa da Moeda ; the latter shall supply such books only upon requisition issued by an ARS, the Ordem dos Médicos or the Ordem dos Médicos Veterinários, according to their respective areas of intervention and competence.

2. The entities mentioned in the preceding paragraph shall distribute the prescription books strictly according to the needs; they shall collect the cost thereof from users.

3. Pharmacies, as well as the State's and private health services, shall forward to the INFARMED a copy of each prescription supplied by them concerning narcotic drugs or psychotropic substances, by the eighth day of the month following the date of the supply.

4. The rules provided for in Law No. 10/91, of 29 April, shall apply to the control of prescriptions by means of computer, as mentioned in Article 18 of Decree-Law No. 15/93.

5. The INFARMED shall inform the competent health service or the Ordem dos Médicos or the Ordem dos Médicos Veterinários, depending on whether the prescription was issued in the exercise of public or private functions, of any situation that it detects when controlling prescriptions showing an abnormal individual consumption of narcotic drugs or psychotropic substances.



Section VI

Register and security

Article 31

General provisions

1. The register books mentioned in this Chapter shall follow the model approved by the INFARMED, shall be numbered and signed on each page by the INFARMED and shall bear formal written inscriptions in their opening and closing pages.

2. Registers shall include neither blank spaces nor non validated additional words, deleted words or corrections; they shall be done in chronological order and numbered in the same order.

3. The entities that are authorized to manufacture any substances or preparations listed in Tables I, II and IV must keep the registers for a period of five years running from the date of the last inscription.

4. In the other cases, registers must be kept for a period of three years running from the date of the last inscription.

5. Registers shall be controlled by the INFARMED.

6. The INFARMED may authorize the replacement of books and manual registers by computer-based registers under conditions such as not to bring down the level of accuracy and safety of the data.

Article 32

Register of incoming and outgoing items

1. In accordance with the provisions of the preceding Article, each incoming or outgoing item consisting of any substances or preparations listed in Tables I, II and IV, must be registered.

2. Books of register as well as the corresponding computer-based registers must be closed by 31 December of each year; the formal written inscription in the closing page must state the total amount of substances and preparations stocked and used during the year, as well as any difference, in excess or in shortage, with respect to previous corresponding registers.



Article 33

Register of incoming and outgoing items

and cycle of manufacture

1. Entities authorized to manufacture any substances or preparations listed in Tables I to IV, but not listed in Table II-A, shall register in the book of register or in the corresponding computer-based register, other than incoming and outgoing items, the beginning of the process of manufacture.

2. Registers of outgoing items and registers of the beginning of the process of manufacture shall include the number of the register of incoming of the items involved.

3. Substances obtained by way of manufacture, including substances obtained by way of a synthesis, shall be registered in the register of incoming items; the register must contain elements allowing for the appropriate link to be established with the register of manufacture.

4. Registers of manufacture must include complete identification and origin of the product, the amount of raw materials used, their name and date of entry in the manufacture section, the amount of product obtained and its serial number.

5. Quantitative differences in the stock of any substances must be recorded separately, but linked with the register of the operation that led to the difference.



Article 34

Register of prescriptions in pharmacies

1. Pharmacies shall record in a special book of register, or in the corresponding computer-base register, any prescription supplied concerning any substances or preparations listed in Tables I and II but not listed in Table II-A; the register shall include the number of the prescription, the name of the medical doctor or veterinary surgeon who issued the prescription, the identification and the age of the buyer and the date of supply; the person responsible shall close the register on 31 December of each year.

2. Any supply of substances and preparations under the terms of Article 17 of Decree-Law No. 15/93 shall be registered autonomously; the register shall include the identification of the sick person, the amount of pharmaceutical product and the date of supply.

3. Pharmacists shall notify the INFARMED within a period of ten days of any supply carried out under the terms of the preceding paragraph; the notification shall include the identification of the pharmacist, the identification of the sick person, as well as the elements mentioned in Article 27, paragraph 3.



Article 35

Notification of removed and missing items

Where books of register, computer-based registers, books with requisitions or prescription books are removed or go astray, the entity responsible for their safekeeping shall, immediately or within a period of 24 hours, so inform the local police authority and the INFARMED, and describe the facts in detail, joining where possible the serial numbers of the documents.



Article 36

Technical measures of protection

1. All entities that are authorized under the terms of this Chapter to keep any substances or preparations listed in Tables I to IV must take adequate technical measures of protection against their being removed or going astray.

2. The entities mentioned in the preceding paragraph shall have the duty to adopt any technical measures of protection that the INFARMED, after having heard the GCDMJ and the respective associations, might impose upon them.

3. Where the requirements imposed are not followed, the authorizations may be revoked, without prejudice to the imposition of any applicable regulatory sanction.



Section VII

Advertising, packing and labelling



Article 37

Ban on advertising

Advertising any substances or preparations listed in Tables I to IV, save in technical publications or information media destined exclusively for medical doctors and other professionals of the health sector, shall be prohibited.



Article 38

Packing and labelling

1. The INFARMED may impose security requirements concerning the opening of containers used for packing any substances or preparations listed in Tables I to IV.

2. Labels fixed on containers containing any substances or preparations listed in Tables I to IV for sale must show the amount, either in terms of weight or in terms of percentage, of the substances included and their common international designation as communicated by the World Health Organisation, along with other elements provided by the law where appropriate.

3. The information leaflet that joins the container includes information concerning the composition of the product, therapeutic indications and doses and shall indicate all its counter-effects, especially whether they entail dependence.

4. Containers containing any substances or preparations listed in Tables I and II shall bear a clear mark consisting of a double red line; external packing for such containers shall not bear that mark.



Section VIII

Miscellaneous



Article 39

Inspections

1. Inspections of any enterprise, establishment or place where any substances or preparations listed in Tables I to IV can be found may be performed at any time; on that occasion documents and registers concerning such substances and preparations shall be exhibited upon request.

2. Before proceeding with an inspection, the staff member of the INFARMED must duly identify himself, by means either of a specific card spelling out his powers of inspection, or a credential.

3. Where the inspected entity refuses to exhibit the documents or registers, the co-operation of the police force shall be requested for the purpose of obtaining such documents or registers; in the meantime measures shall be taken in order to guarantee the effectiveness of the inspection, without prejudice to the provisions of Article 33 of Decree-Law No. 15/93.

4. Within 24 hours of their being detected, offences shall be notified to the competent authorities either for criminal investigation or for proceedings under the legislation on regulatory offences.

5. A written report of each inspection shall be produced; it shall be kept in the records of the inspecting authority unless it is included in a criminal file or a file concerning regulatory offences.



Article 40

Persons in transit

Confirmation, when necessary, of the need to use any substances or preparations mentioned in Article 13 of Decree-Law No. 15/93, for medical reasons, by persons who have crossed the Portuguese border, may be made by the local subdelegado de saúde , or where he is not available, by any medical doctor who is a member of the Ordem dos Médicos.

Article 41

Reports and lists of prescriptions

1. All entities authorized to produce, manufacture, trade in, import, introduce, export or dispatch any substances or preparations listed in Tables I, II and IV, must forward to the INFARMED each year by 31 January a report including the following:

a) Balance upon closing up the register of incoming and outgoing items;

b) Class names and amounts of raw materials used during the year for the manufacture of pharmaceutical or industrial products;

c) Names and amounts of pharmaceutical and industrial products sold during the year, specifying the buying establishments or pharmacies;

d) Amounts imported, introduced, exported or dispatched;

e) Names and amounts of the substances and preparations in stock on 31 December.

2. Enterprises authorized to manufacture any preparations listed in Table III must forward to the INFARMED at that same time the names and amounts of the raw materials used, as well as their proportion with respect to each preparation.

3. Entities and enterprises authorized to manufacture any substances or preparations listed in Tables I, II-B and II-C must also forward to the INFARMED, within a period of 15 days after the end of each trimester, a report on the nature and amounts of raw materials received or used for manufacturing purposes, the nature and amounts of substances or preparations obtained or sold during the ending trimester, as well as the balance.

4. Where the report mentioned in the preceding paragraph concerns raw opium or coca leafs, the contents in active elements must be indicated.

5. Within a period of 15 days after the end of each trimester, pharmacies must forward to the INFARMED a copy of the register mentioned in Article 34, paragraph 1.



Article 42

Other requirements

In accordance with both the international conventions ratified by Portugal and the law, other requirements and restrictions may be imposed upon the import, export, introduction, dispatch or transit of any substances or preparations listed in Tables I to IV.



Section IX

Fees



Article 43

Amounts of fees

1. Fees due for generic requests for an authorization concerning any activity mentioned in Article 2, paragraph 1, shall be as follows:

a) For cultivating, producing, manufacturing or engaging in wholesale trade - PTE 150 000;

b) For import or export - PTE 200 000;

c) For transit - PTE 170 000.

2. Fees applicable to specific requests for concrete operations shall be fixed in accordance with the provisions of Decree-Law No. 48 322, of 6 April 1968.

3. Emoluments or charges other than fees may not be collected.

4. Public legal persons shall be exempted from the payment of fees or any other charges.



Article 44

Recovery and allotment of fees

After approval of the request for an authorization, fees due according to the provisions of the preceding Article shall be recovered under the terms of the organic law of the INFARMED.



CHAPTER III

Authorizations, requirements and control

concerning Tables V and VI

Section I

Production and manufacture

Article 45

Powers of the Directorate General for Industry (DGI)

1. The Director General for Industry, or the entity to whom he delegates powers to that effect, shall be empowered to authorize the production or the manufacture of any classified substances listed in Table V.

2. Decisions granting or refusing authorizations, decisions granting leave to hold on to an authorization and decisions revoking or suspending an authorization shall be notified to the requesting party, the High Commissioner for the VIDA project, the GCDMJ, the district delegation of the Office of the General Inspector of Economic Activities (IGAE), the INFARMED and the regional delegation of the Ministry for Industry and Energy with jurisdiction over the area in which the entity or enterprise is located.



3. Decisions granting an authorization and decisions revoking or suspending an authorization shall be published in the Diário da República.

Article 46

Requests for authorization - Table V

1. Requests for an authorization to produce or manufacture any classified substance listed in Table V and requests for leave to hold on to such an authorization must include the following:

a) Identification of the requesting party by way of an identity card of a physical person or an identification card of a legal person;

b) Identification and professional qualification of the person responsible in technical terms;

c) Indication of who is responsible for preparing and keeping up to date the registers;

d) Names of the substances according to Table V;

e) Potential and methods of production or manufacture;

f) Destination of the products;

g) Whereabouts and graphic description of the factories and warehouses or depots for raw materials or products produced or manufactured.

2. Requests must be accompanied by an extract of the criminal record concerning the requesting parties, the persons mentioned in sub-paragraph (c) above and, in the case of a legal person, the persons who are entitled to act on its behalf.

3. Requests for an authorization and requests to hold on to an authorization must be submitted either to the Directorate General for Industry or to the regional delegation of the Ministry for Industry and Energy; it is incumbent upon the latter to forward requests to the former.

4. Any changes in the elements mentioned in sub-paragraphs (b), (c), (e), (f) or (g) of paragraph 1 must be notified to the DGI within a period of 30 days.



Article 47

Revoked, suspended and lapsed authorizations

1. Authorizations may be revoked or suspended:

a) Where the requirement mentioned in Article 7, paragraph 1, is not met and in case of breach of the provisions of Article 8, paragraph 1;

b) Under the circumstances provided for in Article 9, paragraph 2, and Article 11, paragraph 6, of Decree-Law No. 15/93;

c) Where the requirements and obligations set out in the decision granting the authorization are not met or complied with.

2. Authorizations lapse under the circumstances provided for in Article 8, paragraph 3, and Article 11, paragraph 7, of Decree-Law No. 15/93.



Article 48

Statistical control - Tables V and VI

1. The manufacture of any classified substances listed in Table VI must be notified to the DGI within the period of 30 days from the date of the beginning of the activity.

2. The notification mentioned in the preceding paragraph must include the identification of the requesting party, the location of the premises where such substances are being manufactured, as well as the manufacture potential.

3. Manufacturers must update the information mentioned in the preceding paragraphs.

4. Manufacturers and producers of any classified substances listed in Tables V and VI must have a system for recording their activities and inform the DGI every year of the amount produced or manufactured during that period.

5. The information mentioned in the preceding paragraph shall be transmitted by the DGI to the High Commissioner for the VIDA project, the GCDMJ, the district delegation of the IGAE and the regional delegation of the Ministry for Industry and Energy.

6. The records mentioned in paragraph 4 shall be kept for a period of three years.



Article 49

Safety conditions

Manufacturers and producers of any classified substances listed in Tables V and VI must take adequate safety measures with respect both to such substances and to the records mentioned in Article 48, paragraph 4; in case of them being removed, lost or going astray, manufacturers or producers shall inform the local police authority and the DGI, within 24 hours of having knowledge of the facts.



Article 50

Supervision



The regional delegation of the Ministry for Industry and Energy shall be empowered to supervise the observance of the provisions of both Decree-Law No. 15/93 and this act concerning the production and manufacture of any classified substances listed in Tables V and VI.



Article 51

Fees

A fee of PTE 16 000 shall be due for granting an authorization for carrying out any activity mentioned in Article 45, paragraph 1; that fee shall be collected in accordance with the provisions of Decree-Law No. 5/84, of 5 January.



Section II

Trade

Sub-section I

Licensing and register of operators

Article 52

Powers of the Directorate General for Trade (DGC)

1. The DGC shall have the powers to issue licences authorizing operators involved in import, export, transit and marketing of any classified substances listed in Table V to carry out such activities.

2. A trade number shall be assigned to each operator authorized to get involved in marketing any classified substances listed in Table V.

3. Decisions granting, revoking, suspending or refusing licences, as well as trade numbers assigned by the DGC, shall be notified to the requesting party, the GCDMJ, the IGAE, the DGA and the INFARMED.

4. Decisions granting, revoking, suspending or refusing licences shall be published in the Diário da República.



Article 53

Requests for licences - Table V

1. Requests for licences authorizing operators involved in import, export, transit and marketing of any classified substances listed in Table V to carry out such activities, must include the following:

a) Identification of the requesting party by way of an identity card of a physical person or an identification card of a legal person;

b) Indication of who is responsible for preparing and keeping up to date the registers;

c) An extract of the criminal record concerning the requesting parties, the persons mentioned in sub-paragraph (b) above and, in the case of a legal person, the persons who are entitled to act on its behalf.

d) Names of the substances according to Table V;

e) Whereabouts of the places of trade and warehouses or depots of such substances.

2. Any change in the indications referred to in the preceding paragraph shall be notified to the DGC within a period of 30 days.

Article 54

Revoked, suspended and lapsed authorizations

1. Licences may be revoked or suspended:

a) Where the requirements mentioned in Article 7, paragraph 1, and Article 8, paragraph 1, are not met;

b) Under the circumstances provided for in Article 9, paragraph 2, and Article 11, paragraph 6, of Decree-Law No. 15/93;

c) Where the requirements and obligations set out in the decision granting the authorization are not met or complied with;

d) Where the provisions of Article 53, paragraph 2, and Articles 57 and 58 are not complied with, without prejudice to the imposition of any applicable regulatory sanction.

2. Licences shall lapse in the cases provided for in Article 8, paragraph 3, and Article 11, paragraph 7, of Decree-Law No. 15/93.



Article 55

Register of operators - Table VI

1. The DGC shall have the powers to register, in accordance with Community legislation, operators that are involved in import, export or transit of any classified substances listed in Table VI.

2. Operators involved in marketing any classified substances listed in Table VI named "Acetic anhydrid", "Antranilic acid", "Phenylacetic acid", or "Piperidina" shall inform the DGC of the address of the premises where they trade in such substances and of any subsequent changes.



Sub-section II

Import and export

Article 56

Powers

The DGC shall have the powers to issue import certificates and export authorizations with respect to any classified substances listed in Tables V and VI, in accordance with national and Community legislation.



Article 57

Use of general individual authorizations

1. Exporters who hold a general individual licence issued under the terms of Article 5 of Council Regulation No. 3677/90, of 13 November 1990, as amended by Council Regulation No. 900/92, of 31 March 1992, shall inform the DGC by the end of each trimester, the number of operations carried out, the countries of destination, the name and address of the importer, amount of each substance and how much it is worth, as well as other relevant information relating to the customs clearance.

2. Where any authorization as mentioned in the preceding paragraph is not used, that fact must be notified to the DGC with the same periodicity.



Sub-section III

National trade and trade within the Community

Article 58

Documents and labels

1. Any marketing operations of any classified substances listed in Table V or any substances named "Acetic anhydrid", "Antranilic acid", "Phenylacetic acid", or "Piperidina" must be duly supported by documents; commercial documents, such as invoices and bills of lading, administrative documents, transport documents and other documents concerning the dispatch must include such information as is necessary in order to recognise correctly:

a) The name of the substance as it figures in the Tables;

b) The amount and weight of the substance and, where the substance consists of a blend, the amount and weight of the substance or substances listed in the Tables that are part of the blend;

c) The name and address of the supplier, the distributor and, if known, the final consignee;

d) The trade number mentioned in Article 52, paragraph 2, where any classified substances listed in Table V are involved.

2. Operators entrusted with marketing any classified substances listed in Table V or any substances named "Acetic anhydrid", "Antranilic acid", "Phenylacetic acid", or "Piperidina" shall keep detailed registers of such activities in accordance with the provisions of paragraphs 1 and 5.

3. Documents and registers mentioned in the preceding paragraphs must be kept for a period of at least three years from the end of the calendar year during which the operation mentioned in paragraph 1 was carried out.

4. Operators must control the labels carried by any classified substances listed in Table V or any substances named "Acetic anhydrid", "Antranilic acid", "Phenylacetic acid", or "Piperidina" for the purposes of their being marketed.

5. Labels must include the names of the substances as they figure in the Tables; with respect to any substances listed in Table V, labels must also include the trade number mentioned in Article 52, paragraph 2.

6. Operators who market any classified substances listed in Table V or any substances named "Acetic anhydrid", "Antranilic acid", "Phenylacetic acid", or "Piperidina" must transmit to the DGC every year by 15 January information concerning the transactions, notably the name and address of the client, the amount of each substance and how much it is worth, as well as a declaration written by the client indicating the specific use of the substances in the year before.

7. The provisions of the preceding paragraphs shall not apply to transactions involving the following classified substances listed in Table VI provided that the amounts involved in each operation are not in excess of: "Acetic anhydrid"- 20 litres; "Antranilic acid" or its salts - 1 kg; "Phenylacetic acid" or its salts - 1 kg; "Piperidina" or its salts - 0.5 kg.



Section III

Supervision by the IGAE

Article 59

Powers

1. In co-operation with the INFARMED, the IGAE shall have the powers to supervise all authorized activities involving wholesale trade in, or distribution, acquisition, sale, transport, delivery or possession of any classified substances listed in Table V.

2. The IGAE shall especially have the powers to supervise the activities mentioned in the preceding paragraph that involve any classified substances listed in Table VI, and to investigate and organise proceedings for any regulatory offence provided for in Chapter V, Section III.



CHAPTER IV

Coordination and general supervision

Section I

GCDMJ

Article 60

Powers

1. The GCDMJ shall have the powers :

a) To follow the application of international law and Community law instruments concerning any plants, substances and preparations listed in Tables I to VI, in such a way as to ensure that data transmitted to external entities are congruous and coherent;

b) In co-operation with the other national departments that are active in this area, to supply the competent United Nations bodies with data, information and reports as provided for in the conventions, save information concerning narcotic drugs and psychotropic substances that ought to be forwarded directly by the INFARMED to the International Narcotics Control Board.

c) To spread out at national level information and data obtained from international fora and other sources as appropriate.

2. The GCDMJ shall have such powers as are necessary in order to act as the authority responsible for taking care of any requests received under Article 7, paragraph 8, Article 12, paragraph 10, sub-paragraph (a) or Article 17, paragraph 7, of the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, channelling such requests to the competent departments and seeking to obtain timely responses thereto.

3. Any entities supplying statistical data to the United Nations, the Council of Europe, the International Criminal Police Organisation / INTERPOL or the Customs Co-operation Council relating to narcotic drugs, psychotropic substances, precursors or other chemical products instrumental in obtaining drugs, must forward a copy to the GCDMJ.

4. The powers mentioned in the preceding paragraphs shall be used without prejudice to the powers of the National Programme for Fighting Against Drugs; in particular, the GCDMJ must keep the High Commissioner for the VIDA project informed of its activities carried out under the terms of paragraphs 1 and 2 and forward to him copy of the data mentioned in paragraph 3.



Section II

Directorate General for Customs

Article 61

Powers

1. The DGA shall seek to ensure abidance to the law and customs procedures with respect to the import, export and transit of any plants, substances and preparations listed in Tables I to VI; it may designate specific points for customs clearance thereof.

2. The DGA shall implement adequate procedures for complete identification and control of the merchandise mentioned in the preceding paragraph, in accordance with the specifications included in the respective authorization; it may take samples and have the necessary tests done, in accordance with the law.

3. The DGA shall take such measures as are necessary in order to avoid the substances and preparations from being diverted to destinations other than those indicated in the copy of the authorization; where necessary, it may request the co-operation of other authorities.



Article 62

Administrative co-operation with the Community

The DGA shall be the competent authority under the terms and for the purposes of the provisions of Article 7 of Council Regulation (EEC) No. 3677/90, of 13 December 1990, and Article 7 of Council Directive No. 92/109/EEC, of 14 December 1992.

Article 63

Customs-tax offences

Regulatory offences for the violation of any rules provided in Article 61 shall be processed according to the provisions of the Regime Jurídico das Infracções Fiscais Aduaneiras approved by means of Decree-Law No. 376-A/89, of 25 October.



Section III

Common provision

Article 64

Specific duty to co-operate

Manufacturers, importers, exporters, wholesale traders, retail dealers and other operators, including official customs clearance officers and other persons legally authorized to clear merchandise through customs, forwarding agents, carriers, who intervene in the import, export or transit of any classified substances listed in Tables V and VI, shall notify the IGAE, the DGA, the DGC or the GCDMJ as soon as they have notice of any order or transaction that they suspect can be diverted for the purpose of illegally producing narcotic drugs or psychotropic substances.



CHAPTER V

Regulatory offences and coimas

Section I

General provisions

Article 65

General Rule

Any violation of the duties imposed under the provisions of this act shall be punishable with a penalty under the terms of Articles 65 and 68 of Decree-Law No. 15/93 and its supplementary legislation, with due account to the provisions of the following Articles.

Article 66

Legal persons and the likewise

Where penalties are applied to legal persons and the likewise, their minimum and maximum limits shall be doubled.

Article 67

Powers to apply penalties

1. The Chairman of the board of the INFARMED shall be empowered to apply any penalties and ancillary sanctions provided for in Section II of this Chapter.

2. The Committee for Imposing Penalties in the Economic Field (CACME) shall be empowered to apply any penalties and ancillary sanctions provided for in Section III of this Chapter.



Section II

Regulatory offences and penalties concerning Chapter II

Article 68

Use of authorizations for purposes other

than authorized purposes

1. Whoever holds an authorization to carry out any of the activities mentioned in Article 2, paragraph 1, and uses substances or preparations listed in Tables I to IV, or uses the authorization, for purposes other than the purposes for which the authorization was granted, shall be punished for a regulatory offence with a penalty of PTE 100 000 to PTE 5 000 000.

2. Any violation of any special requirement fixed in decisions granting authorizations that are taken under the terms of Article 8, paragraph 4, shall be punished likewise.

3. The ancillary sanction of disqualification to carry out a given activity for a period of one to three years, may be imposed in the cases mentioned in the preceding paragraphs.

Article 69

Carrying on with an activity without authorization

Carrying on with an activity and thus violating the provisions of Article 8 of Decree-Law No. 15/93 shall constitute a regulatory offence punishable with a penalty of PTE 10 000 to PTE 500 000.



Article 70

Supply without prescription

1. Supplying, not upon a normal or special prescription to that effect, any substances and preparations listed in Tables I to IV shall constitute a regulatory offence punishable with a penalty of PTE 50 000 to PTE 500 000.

2. The ancillary sanction of disqualification to carry out the activity of technical director of any pharmacy for a period of up to two years, may be imposed.



Article 71

Undue supply upon prescription

Any pharmacist, or any person who replaces a pharmacist during the latter's absence or while he is prevented from acting as such, who supplies upon a prescription thus violating the provisions of Article 28, paragraphs 1, 2 and 3, shall be punished for a regulatory offence with a penalty of PTE 25 000 to PTE 250 000.



Article 72

False or wrong information

1. Any person who requests an authorization to carry out any of the activities mentioned in Article 2, paragraph 1, or to hold on to an authorization as mentioned in Article 8, paragraph 1, of Decree-Law No. 15/93, and at that time gives out false or wrong information with a view to obtaining the requested authorization, shall be punished for a regulatory offence with a penalty of PTE 100 000 to PTE 1 000 000.

2. Negligence shall be punishable, in which case the minimum and maximum limits of penalties applicable shall be halved.



Article 73

Surplus: declaration missing or wrong declaration

Where surpluses are not declared in accordance with the provisions of Article 14, or are the subject of false or wrong declarations, that shall constitute a regulatory offence punishable with a penalty of PTE 50 000 to PTE 500 000.



Article 74

Requisition missing

1. Delivering, not upon a requisition as provided for in Article 18, or to persons other than the persons mentioned in Article 20, any substances and preparations listed in Tables I to IV shall constitute a regulatory offence punishable with a penalty of PTE 10 000 to PTE 500 000.

2. Forwarding, not upon a requisition, samples of any preparations listed in Tables III and IV to medical doctors or to veterinary surgeons shall constitute a regulatory offence punishable with a penalty of PTE 10 000 to PTE 100 000.

3. Forwarding samples of any substances and preparations listed in Tables I and II shall be punishable with a penalty as provided for in the preceding paragraph, aggravated by one third.



Article 75

Exports prohibited

Exporting any substances or preparations listed in Tables I, II and IV and thus violating the provisions of Article 25, paragraphs 1, 2 and 4, shall constitute a regulatory offence punishable with a penalty of PTE 50 000 to PTE 1 000 000.



Article 76

Filling in and keeping books, documents and registers

1. Where any books, documents and registers, mandatory under Chapter II, are missing or filled in a false or wrong way, that shall constitute a regulatory offence punishable with a penalty of PTE 100 000 to PTE 1 500 000.

2. Where books, documents, copies and registers are not kept according to the terms of and for the time provided in Chapter II, that shall constitute a regulatory offence punishable with a penalty of PTE 40 000 to PTE 500 000.

3. Where any books and documents mentioned in paragraph 1 are filled in an irregular way, that shall constitute a regulatory offence punishable with a penalty of PTE 10 000 to PTE 250 000.



Article 77

Documents and information not forwarded

Each of the following constitute a regulatory offence punishable with a penalty of PTE 10 000 to PTE 100 000: where prescriptions are not forwarded for purposes of control; where the provisions of Article 34, paragraph 3, are not complied with; where information required by the authorities under the provisions of Article 4 is not disclosed; where any reports or documents mentioned in Article 41 are not forwarded.

Article 78

Duties concerning security and information

1. Any person who is in charge of safekeeping or is responsible for the security of any substances or preparations listed in Tables I to IV and, for reasons of negligence or because that person did not take such measures as are mandatory under Article 36, paragraph 2, gives cause for them being removed or going astray, shall be liable for committing a regulatory offence and punished with a penalty of PTE 10 000 to PTE 500 000.

2. Where the requirements concerning packing, labelling and information that are fixed under the terms of Article 38 are not met, that constitutes a regulatory offence punishable with a penalty of PTE 10 000 to PTE 500 000.

3. Where notification to the police authority, as mentioned in Article 20, paragraphs 2, 3 and 4, is missing or is not done in good time, that constitutes a regulatory offence punishable with a penalty of PTE 10 000 to PTE 250 000.



Article 79

Advertising

Advertising any substances or preparations listed in Tables I to V, where the requirements provided for in this act are not met, constitutes a regulatory offence punishable with a penalty of PTE 100 000 to PTE 2 000 000.



Section III

Regulatory offences and penalties concerning Chapter II

Article 80

Lack of authorization

1. Whoever carries out any of the activities provided for in Article 2, paragraph 2, Article 45, paragraph 1, and Article 52, paragraph 1, without holding the necessary authorization, shall be liable for committing a regulatory offence and punished with a penalty of PTE 100 000 to PTE 4 000 000.

2. The ancillary sanction of disqualification to carry out the activity in question for a period of one to three years, may be imposed.

Article 81

Duties towards the DGI

1. Each of the following constitute a regulatory offence punishable with a penalty of PTE 50 000 to PTE 500 000: where notification of the information mentioned in Article 46, paragraphs 4, and Article 48, paragraphs 1, 2, 3 and 4, is missing; where the registers provided for in Article 48, paragraph 6, are not kept.

2. Each of the following constitute a regulatory offence punishable with a penalty of PTE 10 000 to PTE 250 000: where security measures mentioned in Article 49 are not complied with; where notification as provided for in Article 49 is missing or is not done in good time.



Article 82

Duties towards the DGC

1. Where notification of the information mentioned in Article 53, paragraph 2, Article 55, paragraph 2, Article 57, Article 58, paragraph 5, of this act, or mentioned in Article 2-A, paragraph 2 of Council Regulation (EEC) No. 3677/90, of 13 December 1990, as amended by Council Regulation (EEC) No. 900/92, of 31 March 1992 (provisions concerning addresses of premises where operators trade in any substances listed in Table VI) is missing, that constitutes a regulatory offence punishable with a penalty of PTE 50 000 to PTE 500 000.



2. Each of the following constitutes a regulatory offence punishable with a penalty of PTE 50 000 to PTE 500 000: where any document concerning operations, as mentioned in Article 58, paragraph 1 of this act, or in Article 2, paragraph 1 of Council Regulation (EEC) No. 3677/90, of 13 December 1990, as amended by Council Regulation (EEC) No. 900/92, of 31 March 1992, is missing; where any document as mentioned above is nor correctly filled in; where the detailed registers mentioned in Article 58, paragraph 2, or in Article 2, paragraph 3, of the above-mentioned Regulation, are missing; where documents and registers are not kept or not kept as long as required in Article 58, paragraph 3, or in Article 2, paragraph 4, of the above-mentioned Regulation.

3. Any operator who disregards the rules on labelling provided for in Article 58, paragraph 4 of this act, or in Article 2, paragraph 2 of Regulation (EEC) No. 3677/90, shall be liable for committing a regulatory offence and punished with a penalty of PTE 50 000 to PTE 500 000.

Article 83

False or wrong information

1. Any person who requests an authorization or a licence to carry out any of the activities or operations mentioned in Article 2, paragraph 2, and at that time gives out false or wrong information with a view to obtaining the requested authorization or licence, shall be punished for a regulatory offence with a penalty of PTE 100 000 to PTE 1 000 000.

2. Negligence shall be punishable, in which case the minimum and maximum limits of penalties applicable shall be halved.



Article 84

Violation of the duty to co-operate - Tables V and VI

Any person, as mentioned in Article 64, who under the circumstances described in that Article, does not notify - although being in a position to do so - any suspicious order or transaction concerning any classified substances listed in Tables V and VI that can be diverted towards the illegal market shall be punished for a regulatory offence with a penalty of PTE 50 000 to PTE 750 000.



Section IV

Proceeds from penalties

Article 85

Allocation

1. Proceeds from penalties shall be allocated as follows:

a) with respect to penalties imposed by the INFARMED, 60% to the State and 40% to the INFARMED;

b) with respect to penalties imposed by the CACME, 60% to the State, 10% to the DGI, 10% to the DGC, 10% to the IGAE and 10% to the fight against drug-dependency; the DGI shall share its stake with its regional delegations according to the place where the offence was committed.

2. The allocation of the proceeds from penalties to the fight against drug-dependency shall be regulated by way of a common decision of the Minister of Justice and the member of Government responsible for the National Programme for Fighting Against Drugs.



CHAPTER VI

Final and transitional provisions

Article 86

Special measures

1. The substances named "Anphepramone", "Benzephetamine", "Chlobenzorex", "Ethylamphetamine", "Phencamphamine", "Phemproporex", "Flunitrazepam", "Mephenorex", "Secbutabarbital", "SPA" or "Lefetamine", listed in Table IV, shall be submitted both to special prescriptions under the terms of Article 27 and to the control measures provided for in Article 15, paragraph 6, and Articles 16, 18, 28, 29 and 34, as well as Article 41, paragraph 3.

2. Pending the substance named "Chlobenzorex" being listed in the tables appended to the United Nations Conventions, the INFARMED may decide that authorizations for the import of that substance, as mentioned in Article 22, paragraph 2, are not required.



Article 87

Time-limits for implementing new measures

1. The measures provided for in Article 18, paragraph 1, and Article 19 (book with requisitions), Article 27, paragraphs 2, 3 and 5 (medical prescriptions), Article 31, paragraph 1, (book of registers), Article 36, paragraph 2, (security measures) and Article 38 (packing and labelling), shall be implemented within one year from the date of the entry into force of this act.

2. Pending the implementation of the measures mentioned in the preceding paragraph, the rules of Regulative Decree No. 71/84, of 7 September, shall apply mutatis mutandis.

3. The same time-limitation shall apply to the computerisation of the control of prescriptions.



Article 88

Application in the Autonomous Regions

Powers conferred in this act to entities of the central administration that exercise no powers in the Autonomous Regions shall be understood to be conferred upon their respective counterparts in the regional administrations.



Article 89

GCDMJ

Any references in this act to the GCDMJ shall be understood to make reference to the Office of Planning and Coordination of the Fight against Drugs, pending the latter's change in structure and name.

Article 90

Norms revoked

The following shall be revoked:

a) Regulative Decree No. 71/84, of 7 September;

b) Regulative Decree No. 7/90, of 24 March;

c) Orders No. 167/87, of 10 March, No. 217/90, of 24 March, and No. 218/90, of 24 March.