Drug precursors - operator registration
To carry out the Operator Registration, in the case of entities involved in the production, manufacture, transformation or storage of substances listed in Category 2 of Annex I of Regulation (EC) No. 273/2004, of the European Parliament and of the Council, of 11 February, with the amendments introduced by Regulation (EC) No. 219/2009, Regulation (EU) No. 1258/2013 and Delegated Regulation (EU) No. 1443/2016.
Although Regulatory Decree No. 61/94, of 12 October, in the version given by Regulatory Decree No. 28/2009, establishes the obligation to register economic operators involved in production, manufacturing, transformation and storage of category 3 substances, the provisions of Regulation (EC) no. 273/2004, of the European Parliament and of the Council, of 11 February, prevail, which only requires operator registration in the case of category 2 substances. However, in all situations where the operator intends to register, even if not obliged to do so, DGAE services accept the corresponding request, as it is covered by national legislation.
Procedure and requirements
- The operator submits the request for Operator Registration to DGAE, with the services of that General Directorate having 10 working days to request, by notification, the operator to present the missing elements, within the legally established period.
- In cases where the applicant does not deliver the missing elements, within the established deadline, DGAE does not follow up the request and informs the operator.
- After analyzing the conformity of the elements presented, the application may obtain an unfavorable opinion, in case there are reasonable reasons to doubt the competence and suitability of the applicant, or favorable, being assigned an operator registration for the exercise of the activity referred to in the scope of the respective request.
- DGAE prepares a document proving the operator registration, which is sent to the applicant through electronic notification.
- Dias úteis das 09:00h às 13:00h.
- Dias úteis das 14:00h às 18:00h.