Licences relating to industrial production of pharmaceuticals
- Permit or other obligation
- Nationwide
- Public service
Licences relating to industrial production of pharmaceuticals are pharmaceutical plant, contract manufacturing, and contract analysing licence. A licence may be granted to an applicant that meets the requirements of article 1 of the Medicines Decree.
Do the following
Applications for a licence can be submitted to the registry of Fimea in a free format.
To whom and on what terms
The applicant must present information about the responsible manager who meet the requirements of article 9 of the Medicines Act and, when needed, about a person who meets the qualification requirements of the Medicines and Veterinary medicines directive if the applicant intends to produce preparations in whole or in part. Additional requirements are described in article 1 of the Medicines Decree.
Deadline
Prior to starting the operation
Processing time
90 days or 30 days (changes of licence), the processing time does not include the time used to providing additional clarification or providing a clarification. Inspection of the applicant’s premises and activity shall be carried out withing the processing time.
Period of validity
Until further notice if the activity is in accordance with good manufacturing practices for medicinal products.