Licences

Application for a manufacturing licence

The Medicines Act No. 93/1994, as amended, stipulates that a manufacturing licence can only be held by those granted such a licence by the Minister. An application for a manufacturing 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 marketing authorisations.

Each manufacturing licence is valid for the planned manufacturing site only.

According to Regulation No 893/2004 on manufacturing 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. Address of the manufacturing site and the location of the quality assurance

4. General description of the planned activity

5. Drawings of premises

6. Summary of main equipment

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

manufactured

8. Summary of individual steps in the manufacturing process of the medicine(s) which

are manufactured at the firm

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

10. Name of technical manager and a CV

11. Name of Qualified Person 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 a manufacturing licence, the applicant must submit a new application and update the information stated in points 1-11 above.

IMA issues a manufacturing licence to a manufacturing licence holder, where it is stated that he fulfils the requirements on manufacturers within the European Economic Ares. The licence specifies which manufacturing elements and medicinal products it addresses as well as the name of the Qualifies Person and the address of the manufacturing site. The licences shall be issued in accordance with rules applicable on EEA and/or rules of The World Health Organisation

Amendment to the manufacturing licence

The manufacturing licence holder shall apply to IMA for amendments to the manufacturing licence regarding those items, which were the basis of the manufacturing 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) inline with the time from the request for additional information until its receipt by IMA.