Licences for import and wholesale distribution of medicinal products

Applications for import and wholesale distribution of medicinal products

The Medicines Act No. 93/1994, as amended, stipulates that a licence to import finished medicinal products and ingredients and for their wholesale distribution can only be held by those granted such a licence by the Minister. An application for an import and wholesale licence must be submitted to the Ministry of Welfare on a specific form.

The Ministry of Welfare requests IMA for dicta on all applications for import and wholesale licence.

Each import and wholesale licence is valid for a maximum period of five years.

According to Regulation No 699/1996 on import and wholesale distribution of medicinal products, the application must be accompanied by the following information:

1. Name, address, ID and Phone number of the firm

2. Name, address, ID and Phone number of the person applying on behalf of the firm

3. General description of the planned activity

4. Drawings of premises

5. Summary of main equipment

6. Summary of medicinal products and pharmaceutical forms which are planned to be

imported and/or wholesale distributed

7. Summary of main components of the firm's quality assurance system

8. Name of technical manager and a CV

9. Name(s) of Qualified Person(s) and a CV, if the QP is not the technical manager

IMA assesses the application based on submitted data and after an inspection at the applicant's firm.

IMA has 90 days from the receipt of a new application to assess it.

If further information is needed it shall be sent in writing to the applicant and the time limit to assess the application is extended accordingly (clock-stop) in line with the time from the request for additional information until its receipt by IMA.

In the case of an application for a renewal of import- and wholesale licences, the applicant must submit a new application and update the information stated in points 1-9 above.

Amendment to the import- and wholesale licences

The licence holder shall apply to IMA for amendments to the import and wholesale licences regarding those items, which were the basis of the licence.

IMA has 30 days from receipt of the application for amendment to assess it. In specific cases that period can be extended to up to 90 days.

If further information is needed it shall be sent in writing to the applicant and the time limit to assess the application is extended accordingly (clock-stop) in line with the time from the request for additional information until its receipt by IMA.