How to apply for a pharmacy licence
How to apply for a pharmacy licence
The Finnish Medicines Agency invites applications for any new or vacated pharmacy licence by a public notice published on its website. Public notices will no longer be published in the Official Gazette after 1 April 2022. Applications for a pharmacy licence must be submitted electronically or in writing using a form confirmed by the Finnish Medicines Agency within 30 days of the publication of the notice.
Pharmacy licence notices state:
- information on the location of the pharmacy;
- the terms of the pharmacy licence referred to in section 40(2); and
- The order of magnitude of the pharmacy to be announced referred to in subsection 2 and the accounting periods on which the magnitude of the pharmacy is based, as defined by the Finnish Medicines Agency.
The size of the pharmacy is based on the average turnover of the pharmacy's pharmaceutical sales, calculated from the moment the pharmacy licence became vacant for the last three financial years for which the information is available. Pharmacies are divided into size categories based on their turnover of pharmaceutical sales as follows:
- If the turnover of pharmaceutical sales does not exceed 50 per cent of the average turnover of pharmaceutical sales in private pharmacies in the country, the pharmacy belongs to category 1;
- If the turnover of pharmaceutical sales exceeds 50 per cent and does not exceed 100 per cent of the average turnover of pharmaceutical sales in the private pharmacies in the country, the pharmacy belongs to category 2;
- If the turnover of pharmaceutical sales exceeds 100 per cent and does not exceed 150 per cent of the average turnover of pharmaceutical sales in the private pharmacies in the country, the pharmacy belongs to category 3;
- If the turnover of pharmaceutical sales exceeds 150 per cent of the average turnover of pharmaceutical sales in the private pharmacies in the country, the pharmacy belongs to category 4.
Applicants for a pharmacy licence must meet the requirements of the Medicines Act for granting a pharmacy licence:
- the applicant is a licensed pharmacist in Finland
- the applicant has not been declared bankrupt
- no guardian has been assigned to the applicant and their functional capacity has not been restricted
- the applicant has not been sentenced by a final judgement for an offence essential to pharmacy operations.
Fimea receives this information on applicants from different official registers for applicants living in Finland. If the applicant for a pharmacy licence resides permanently in a country other than Finland, the applicant must, if necessary, submit the documents received from the authorities of their country of residence, indicating the aforementioned matters.
Applicants for a pharmacy licence must attach to the application their curriculum vitae or other documents indicating the factors to be taken into account in the assessment referred to in section 43b, subsection 3.
The condition laid down in the pharmacy licence on the operation of a subsidiary pharmacy obliges the subsidiary pharmacy in question to be kept in operation, in which case the pharmacy licence matter and the keeping of the subsidiary pharmacy are discussed together and one decision is issued thereon. The subsidiary pharmacies as a right must be applied for separately and a separate decision will be issued on them.
Applications and e-services
The applications and their appendices are submitted to Fimea in the e-services or to the registry before the end of the application period. You can log in to e-services at: asiointi.fimea.fi
When applying for a pharmacy licence, logging in to the e-services takes place using Suomi.fi e-Identification, i.e. using online banking IDs, a mobile certificate, a FINEID card issued by the Digital and Population Data Services Agency (identity card issued by the police) or a professional ID card of a health care professional.
The application must be completed and submitted in the e-services before the end of the application period. After the application period has expired, any supplements to the application can be submitted to Fimea using the e-services messaging function or to Fimea's registry
Fax: +358 29 522 3002
Postal address: Kirjaamo, P.O. Box 55, 00034 FIMEA.
Fimea primarily delivers the pharmacy licence decisions electronically to the email address provided by the applicant.
yhteystietolaatikko Sinnemäki, Rosenberg (englanti)
- Juha Sinnemäki, Senior Pharmaceutical Officer, +358 (0) 29 522 3260
- Pirjo Rosenberg, Senior Pharmaceutical Officer, phone +358 (0)29 522 3246
The email address format is email@example.com