Articles 31 and 34 of the royal decree of 06.09.2017 regulating narcotics and/or psychotropic substances require a prior import or export authorisation for each import or export of products referred to in annexes I, II, III and IV.
The said authorisation may only be used once and may include a maximum of fifteen different products.
The import and export within the framework of this legislation concerns the actual transfer to/from Belgian territory.
An import or export authorisation is not required for the following products, insofar as these are used for analytical purposes:
- preparations with a concentration not exceeding 1 mg/ml and a maximum content of 1 ml per preparation on condition that the laboratories concerned report to the Belgian Early Warning System on Drugs;
- small quantities of products, which exclusively contain substances referred to in annex IV.
Should a foreign government still require a Belgian import authorisation, then the FAMHP will supply a “letter of no objection” (LONO).
An export authorisation is not required for exports in accordance with the Model Guidelines of 25 May 1996 for the International Provision of Controlled Medicines for Emergency Medical Care of the WHO as stated in Annex VII of the royal decree of 06.09.2017 regulating narcotics and/or psychotropic substances.
Each import or export authorisation will be drawn up in different copies. The specific destination will be mentioned in the coloured right margin of each copy.
The original signed copy of an import authorisation must be sent to the foreign exporter who, on the basis of this Belgian import authorisation, can in turn request an export authorisation from the foreign competent authorities.
The products that are to be delivered may only be exported once the exporter has received the export authorisation. So bear in mind that this process takes some time and involves additional administrative costs.
Conversely, an export authorisation can only be issued by the FAMHP Narcotics Team if the foreign authorities have issued an import authorisation or LONO.
Here too, the products may only leave Belgium to the foreign country once the designated copies of the export authorisation have been included with the shipment.
It is permitted to request a single Belgian export authorisation that combines different foreign import authorisations from the same importer.
All export of products from Annexes I, II and IV is subject to a prior inspection by the competent official at the FAMHP.
The competent official must also be notified of the import of these products before the packaging may be broken.
The details of the competent official are mentioned on the letter accompanying the import or export authorisations.
These inspections do not apply to:
- the import and/or export of small quantities of products that are exclusively intended for analytical purposes (reference standards);
- the import of products by a pharmacist based on a medical doctor's declaration.
An import authorisation is valid for six months after issue.
An export authorisation is valid for three months and may be extended in accordance with the validity as stated on the import authorisation which has been issued by the competent authorities of the recipient country, without exceeding a maximum validity of six months.
An import or export authorisation can only be requested if the applicant has a valid activity licence or end user licence for the import or export activities.
The holders of a ”small quantities of narcotics and/or psychotropic substances” licence (this licence is subject to an extinction procedure) are not permitted to import narcotics and/or psychotropic substances. They must apply to a retail or hospital pharmacy who can import the products for them on the basis of an order form signed by the official responsible for the “small quantities” licence. It is however strongly recommended to switch to an end user licence which will give them import rights.
- Import or export authorisations must be electronically requested via the NDS-web system.
Requests sent by e-mail will not be processed.
- In case of medicines being imported via a retail or hospital pharmacy, a copy of the medical doctor's declaration justifying this import must be included with the request.
- Requests for export authorisations must be accompanied by an import authorisation or LONO that was issued by the competent authorities of the destination country.
Import and export authorisations are issued on security paper and may only be sent by post to the Narcotics Team of the FAMHP.
Handling a request can take 4 to 15 working days, depending on how the request is made (written/electronically via NDS-web).
The FAMHP must report imported or exported quantities at regular intervals to the INCB (International Narcotics Control Board).
For this reason, it is essential that in the event of effective import or export these authorisations be validated (endorsed) as soon as possible if no inspection has yet taken place by the FAMHP.
The procedure to be followed has been explained on the back of the copy with the right margin in blue.
Unused authorisations must be returned no later than on the date of expiry to the Narcotics Team of the FAMHP.
If the authorisations were requested through NDS-web, then they must also be endorsed in NDS-web with a “0” and state “authorisation cancellation”.
Any authorisation issued is subject to a payment that varies according to the need for an on-site product inspection (see Articles 33 and 36 respectively of the Royal Decree of 06.09.2017).
Type of application
These payments will be indexed each year.
Please note that these amounts no longer need to be paid up-front but will be invoiced once the authorisation has been issued.
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