Drug precursors – Registering as an operator (category 2 substances)

Drug precursors are chemical substances that have legitimate uses in industry (such as in the production of medicines, cosmetics, fertilisers, plastics or inks), but which can also be used for illicit purposes.

For this reason, operators who produce, manufacture, transform or store category 2 drug precursor chemicals must register with the Directorate-General for Economic Activities (DGAE).

Service channels

  • Register online

    Register drug precursor operators

Procedure and requirements

Documentos and requirements

On the form, you will need to include:

  • name and address of the registered office of the operator applying for registration;
  • identification details for the person responsible for registering the operator;
  • job description and duties of the responsible person;
  • identification of persons who can bind the undertaking;
  • address of all places where scheduled category 2 substances are stored, produced, manufactured and processed;
  • name and CN (combined nomenclature) code of the substances and/or their salts (where having such salts is possible) for which registration is applied for;
  • in the case of a mixture or a natural product, the name of the product and the name and maximum percentage of each identified substance (and/or its salts, if applicable) must be mentioned.

You will also need to attach the following documents to the form:

  • declaration identifying the person responsible for ensuring that the operator’s business activity complies with the law. This person (director, administrator, managing partner or manager) must be authorised to represent the operator and to make the necessary decisions to carry out those duties;
  • criminal record certificates of all the individuals identified in the form and in all the documents submitted for registering the operator;
  • for legal entities:
    • copy of the operator’s tax identification card,
    • access code to the permanent certificate or certified copy of the up-to-date current/valid business register certificate;
  • if you are a sole trader:
    • copy of the declaration of commencement of activity stating the relevant business activity.

To complete the operator registration form, you will need to sign in using one of the following means of authentication:

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

If you do not yet have a Digital Mobile Key, learn how to activate your Digital Mobile Key.

If you want to use your Citizen Card, find out how to sign in with a Citizen Card.

Procedure

To apply for registration, follow the steps set out below.

  1. Click on ‘Realizar serviço’ [Use service].
  2. Sign in using your Digital Mobile Key, Citizen Card or your lawyer’s, solicitor’s or notary’s digital certificate.
  3. Complete the online form and attach the necessary documents.
  4. Click on ‘Submeter’ [Submit].

Examination of the application

  1. Once the DGAE receives the application, if anything is missing it will request the missing documents within 10 working days.
  2. If you do not submit the missing documents within 10 working days, the DGAE will not process your application.
  3. After the information/documents submitted have been examined, the application may:
    • not be approved if there are reasons to doubt the operator’s technical competence and capacity
    • be approved. An operator will be registered for the business activity indicated in the application form
  4. If the application is approved, the DGAE will prepare a proof of registration document for the operator, which will be sent to the email address provided in the application. 

If you still have any queries, please watch the video explaining the operator registration process.

How much

Registering as an operator is free of charge.

Validity

The operator’s registration will be valid for three years.

You must apply to renew the registration at least 20 days before the expiry date.

Obligations

Registration is compulsory for operators who produce, manufacture, transform or store category 2 drug precursor chemicals. Operators must register before starting to trade.

Registration is optional in the case of category 3 drug precursor chemicals. Companies may decide whether they want to register or not.

The information in the register must always be up to date. If there are any changes, a new registration application must be made within 10 working days.

Additional Data

What are category 2 drug precursor chemicals?

In accordance with Council Regulation (EC) No 111/2005 of 22 December 2004, the following fall within category 2:

  • subcategory 2A: acetic anhydride,
  • subcategory 2B: phenylacetic acid, anthranilic acid, piperidine and potassium permanganate.

What are category 3 drug precursor chemicals?

In accordance with Council Regulation (EC) No 111/2005 of 22 December 2004, bulk chemicals that may have various types of use in manufacturing processes (e.g. acetone, hydrochloric acid) are included in category 3.

Legislation, refusals, contests, claims

Legislation

Reasons for refusal

  • The information provided in the form and/or mandatory attachments does not meet the conditions required under the law.
  • Missing documents.
  • Unresolved questions concerning use of the scheduled substances.

Means of opposition/Complaint to the Ombudsman

Complaint

  • You may lodge a complaint with the department that issued the decision within 15 days of being notified of that decision.
  • When a complaint is required (i.e. is mandatory) for subsequently bringing an action before an administrative court, the effects of the decision issued are suspended. An optional complaint only has a suspensive effect if the body competent for hearing the complaint considers that its immediate enforcement would cause damage to the complainant that would be irreparable or difficult to redress, and where a suspension would not cause greater harm to the public interest.
  • The authority has 30 days to respond to your complaint. In the case of a complaint that is required for procedural purposes, where no decision has been taken within the time limit, complainants may use the appropriate legal means to pursue their claim.

Appeal to a higher-ranking body

  • You may lodge an appeal with the highest hierarchical superior of the perpetrator of the act or omission, unless competence for the decision is delegated or sub-delegated, in which case it is submitted to the perpetrator of the act.
  • You have 30 days after becoming aware of the decision in which to lodge an appeal when an appeal is mandatory for bringing an action before the administrative court. In other situations, the time limit for lodging the appeal is the same as that laid down for filing a court action.
  • The perpetrator of the act has 15 days, or 30 days if there are any other parties to the proceedings, to decide on the appeal and refer it to the body responsible for hearing the appeal, notifying the appellant of this when they do so.
  • The competent body must decide on the appeal within 30 days from the date on which it was referred the case, which may be extended to 90 days.
  • When an appeal is required (i.e. is mandatory) for bringing an action before the administrative court, the effects of the decision issued are suspended. An optional complaint only has a suspensive effect if the body competent for hearing the complaint considers that its immediate enforcement would cause damage to the appellant that would be irreparable or difficult to redress, and where a suspension would not cause greater harm to the public interest.
  • If an appeal to a higher body, required for procedural purposes, is dismissed or no decision has been made within the time limit, you have the opportunity to challenge the act of the subordinate body before a court or to assert your right to have that body fulfil its duty to make a decision on your appeal.

Administrative action

You may bring a special or ordinary administrative action before the competent administrative court.

Where the law states that a prior complaint or appeal is necessary, you must make one before bringing an administrative action.

Special administrative actions may be brought when:

  1. An authority has issued an unlawful decision.
  2. An authority was required to issue a decision and failed to do so.
  3. An authority was required to issue a rule and failed to do so.

The time limits for bringing an action are as follows:

  • three months after being notified of the decision, when the decision can be annulled;
  • at any time, when the decision is not valid or the authority failed to issue a decision that was required of it.

Until the court issues a ruling, the decision issued by the authority shall remain suspended, in particular where it concerns the payment of a certain sum not related to a fine and where a guarantee has been provided.

Administrative actions may be brought where the decision does not set out any special rules, namely, in the following situations:

  1. where the authority is ordered not to issue a decision where it is likely that the decision will adversely affect the rights of the person concerned;
  2. where the authority is ordered to take the necessary steps to restore rights or interests that have been infringed;
  3. where the authority and members of its agencies, officials or other staff have civil liability;
  4. where there is an order to pay damages, when the decision issued by the authority takes precedence over the public interest;
  5. in relation to the interpretation, validity or performance of contracts.

You may bring an action at any time, except for claims to cancel contracts, which must be brought within six months of signing the contract or, in the case of third parties, of being notified of the contract.

Complaint to the Ombudsman

  • You may lodge a complaint with the Ombudsman against the authority that issued the decision at any time.
  • There is no time limit for the Ombudsman to reply.
  • The Ombudsman cannot change the decision issued by the authority.

Competent Entity

Direção-Geral das Atividades Económicas

Operation hours

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