Annual authorisation

Request for an annual authorisation

Manufacturers, wholesalers, importers and exporters of narcotic drugs and psychotropic substances must have an annual authorisation.

Indeed the sale of narcotic drugs (substances such as those defined in the royal decree of 31st December 1930 (French version)) and psychotropic substances (substances such as those defined in the royal decree of 22 January 1998 (French version) ) is subject to a request for authorisation from the Narcotic Drugs Department of the Federal Agency for Medicines and Health Products (FAMHP). The request must contain the following information:

• the name of the firm, the registered office and its place of operation
• for each place of operation : the family name and first name of the person who is responsible, and his representative(s), for narcotic drugs and psychotropic substances, and also a document signed by the person responsible for the company (depending on his status) designating him as the person responsible for narcotic drugs and psychotropic substances ;
• the e-mail address telephone and fax number of each operating location ;
• the precise nature of the activities for which the authorisation is requested

The person responsible and the representative(s) must all sign the request for authorisation.

Once authorisation is granted it is valid till 31st December of that year. Thereafter it must be renewed annually.

Annual renewal of the authorisation

A request for renewal must be submitted to the Narcotic Drugs Department in time, before 15 January of each year. It must show the information required for a request for authorisation. It is important to mention the authorisation number that was previously granted.

Information changes relating to an authorisation

Any change in the information given for a request for authorisation must be signaled without delay to the Narcotic Drugs Department. The changed request must be signed by the interested persons.

If there is a change in company status, VAT number, or commercial registry number, you must provide a copy of the change published in the Belgian Official Journal.

Fees

A fee of 161,11 € is to be paid each year for any request for authorisation (whatever the date when the request is submitted) and for any authorisation renewal.

A fee of 42,12 € is to be paid for each change (to be indicated without delay to the Narcotic Drugs Department). However if several changes are made at the same time the fee remains 42,12 €.

If the changes coincide with the request to renew the authorisation, one fee of 161,11 € is to be paid.

These different fees should be transferred to account of FAMHP

IBAN : BE96 6790 0221 2105
code SWIFT : PCHQBEBB

Poste financière, chaussée d’Anvers 59 à 1100 Bruxelles –