Applying for a licence to produce, manufacture, transform or store drug precursor chemical substances

Operators that want to be involved in the production, manufacture, processing or storage of Category 1 drug precursor chemicals need a licence from the Directorate-General for Economic Activities (DGAE) in order to work with these substances.

Drug precursor chemicals are different substances that can be used legitimately (in the chemical industry, for example), but which require special care because they can also be used in the illegal production of narcotics or psychotropic substances.

The licence to work with these substances must be applied for online and costs EUR 100.

Service channels

Procedure and requirements

Documentos and requirements

Who needs this licence?

The licence is compulsory for anyone who wants to work with Category 1 drug precursor chemicals.

When submitting your licence application, you must attach the documents listed below. These documents are mandatory for the application to be accepted (approved):

  • If the operator is a legal person:
    • the operator’s tax identification card (company card or legal person card),
    • the access code to the permanent certificate or extract from the commercial register.
  • If the operator is a natural person – a declaration of commencement of activity stating the activity to be carried out.
  • Declaration on the appointment of a responsible person to ensure that the activity will be carried out in accordance with the law, who is authorised to represent the operator and take the decisions necessary for the performance of their duties.
  • Layout plan of the operator’s premises (including warehouses or storage areas) to be used for the production, manufacture, processing or storage of drug precursor chemicals.
  • Declaration that includes all the necessary information showing that adequate measures have been taken to ensure that unauthorised persons do not remove drug precursor chemicals from the premises.
  • Criminal record certificates for all the persons listed on the licence application form and in the documents submitted with the application (find out where to obtain criminal record certificates).

The application will be rejected (refused) in any of the following cases:

  • if the form is not duly completed;
  • if any of the mandatory elements are missing (see list above);
  • if the information given on the form or in any of the documents is not complete or does not fulfil all the legal requirements;
  • if there are reasonable grounds to suspect that the substances are destined for the manufacture of drugs or psychotropic substances.

Procedure

You will need to sign in using one of the following means of authentication:

  • your Citizen Card;
  • the Digital Mobile Key (CMD);
  • a lawyer, solicitor or notary’s digital certificate.

Once you have your chosen means of authentication to hand, follow the steps below.

  1. Click on ‘Access the service’.
  2. Complete the form.
  3. Attach all necessary documents.
  4. Click on ‘Submeter’ [‘Submit’].

You will be informed of the decision within 60 days of submitting your application

If the application is accepted, the DGAE will issue the licence and send it by letter to the address indicated by the applicant.

You have 10 working days to pay the fee for issuing the licence

Together with the licence, you will receive a slip with details for paying the licence fee. You must pay the fee within 10 working days.

If you don’t pay the fee within 10 working days, your licence will be withdrawn.

How much

There is a fee of EUR 100 for issuing the licence.

Validity

The licence is valid for 3 years.

In order to keep the licence, you must inform the DGAE about your activity every year

Every year between 1 January and 31 March, you will have to communicate some information to the DGAE about your activity over the previous year and your planned activity for the coming year. If you fail to do so, the licence may be suspended or revoked (cancelled).

To find out how to communicate information about your activity to the DGAE, see Submitting the annual notification of information on activity involving drug precursor chemicals.

If there are changes in your activity, you have 10 days to inform the DGAE

If there is any change in your activity that means that the information you gave when applying for the licence is no longer true, you must repeat the steps in ‘How to apply for a licence’ within 10 days.

You can renew the licence up to 10 days before the end of the 3 years for which the licence is valid

To do so, you should repeat the steps indicated under ‘How to apply for a licence’.

There are situations in which the licence may be suspended or revoked (cancelled)

The licence will be revoked if you cease to operate as an operator in drug precursor chemicals.

The licence will be suspended (temporarily withdrawn) or revoked:

  • if it is found that you do not comply with all the legal obligations;
  • if there is a technical accident, theft, deterioration of substances or other irregularity that endangers public health or is related to the illegal drug precursor chemicals market.

The DGAE will notify the following entities about the issuing, revocation or suspension of the licence, and these may react (according to their legal responsibilities and depending on the situation):

  • General Directorate for Intervention on Addictive Behaviours and Dependencies (SICAD),
  • Economic and Food Safety Authority (ASAE),
  • National Authority for Medicines and Health Products (INFARMED),
  • Polícia Judiciária (PJ) [Judicial Police],
  • Tax and Customs Authority (AT).

Additional Data

What are Category 1 drug precursor chemicals?

They are scheduled substances in Category 1 under Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004. Since substances may subsequently have been added to this list, we advise that you consult the most up-to-date version of Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004.

In October 2022, the following were scheduled substances:

  • 1-phenyl-2-propanone
  • methyl alpha-phenylacetoacetate (MAPA)
  • ethyl alpha-phenylacetoacetate (EAPA)
  • methyl 2-methyl-3-phenyloxirane-2-carboxylate (BMK methyl glycidate)
  • 2-methyl-3-phenyloxirane-2-carboxylic acid (BMK glycidic acid)
  • N-acetylanthranilic acid
  • alpha-phenylacetoacetamide (APAA)
  • alpha-phenylacetoacetonitrile (APAAN)
  • isosafrol (cis + trans)
  • 3,4-methylenedioxyphenylpropan-2-one
  • piperonal
  • safrole
  • methyl 3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylate (PMK methyl glycidate)
  • methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate (MAMDPA)
  • 3-(1,3-benzodioxol-5-yl)-2-methyloxirane-2-carboxylic acid (PMK glycidic acid)
  • 4-anilino-N- phenethylpiperidine (ANPP)
  • N-phenethyl-4-piperidone (NPP)
  • ephedrine
  • pseudoephedrine
  • norephedrine
  • ergometrine
  • ergotamine
  • lysergic acid
  • If you want to work with drug precursor chemicals from Category 2 or Category 3, you must register as an operator. To find out how to register, see Drug precursors – registering as an operator.

Legislation, refusals, contests, claims

Legislation

Means of opposition/Complaint to the Ombudsman

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Competent Entity

Direção-Geral das Atividades Económicas

Address: Avenida Visconde de Valmor n.º 72 1069-041 Lisboa

Phone number: 217 919 100

Email address: dgae@dgae.gov.pt

Web url: www.dgae.gov.pt

Operation hours

  • Dias úteis das 09:00h às 13:00h.
  • Dias úteis das 14:00h às 18:00h.