How to obtain a pharmacy licence: step-by-step procedure
Before submitting documents to the State Service of Ukraine on Medicines and Drugs, it is important to check not only the document package itself but also the pharmacy’s actual readiness: premises, equipment, personnel and material and technical resources.
1. Premises review
We analyse the area, layout, location, accessibility and compliance of the premises with the licensing requirements. It is particularly important to do this before entering into a long-term lease or starting renovation work.
2. Personnel and material and technical resources
We verify the qualifications of pharmaceutical personnel, equipment, conditions for storing medicinal products and other requirements applicable to the operation of a pharmacy establishment.
3. Preparation of documents
We prepare the application, information on material and technical resources, documents relating to personnel and premises, orders and other documents depending on the format of the pharmacy establishment.
4. Submission and pre-licensing inspection
We submit the documents to the State Service of Ukraine on Medicines and Drugs and provide support during the pre-licensing inspection of compliance of the material and technical resources and staffing arrangements.
Key requirements for pharmacy premises
The requirements for the area and arrangement of the premises depend on the format of the pharmacy establishment and its location. For a standard pharmacy, the minimum total area is:
30 m²
urban-type settlement
Separate requirements for pharmacies in healthcare facilities:
For pharmacies located in healthcare facilities, legislation establishes separate area requirements. In cities and urban-type settlements — from 30 m², in villages — from 18 m². The area of a pharmacy outlet must be at least 10 m².
In addition to the area, the layout of the premises, medicinal product storage areas, accessibility for persons with reduced mobility and compliance of the material and technical resources with the declared type of activity are also checked.
Pharmacy equipment and material and technical resources
The list of equipment depends on the format and product range of the pharmacy establishment. Basic equipment includes, in particular:
✓
Pharmacy cabinets and shelving
✓
Necessary equipment for storing medicinal products
✓
Refrigeration equipment
✓
Thermometers and hygrometers
Important: a preliminary review should be carried out before leasing the premises and beginning renovation. Correcting non-compliance after the pharmacy has been fitted out usually requires more time and additional costs.
Timeframe for obtaining a pharmacy licence
Once the premises, personnel and complete package of documents have been prepared, the application is submitted to the State Service of Ukraine on Medicines and Drugs. The timeframe for deciding whether to issue or refuse a licence is up to 10 business days from the date the licensing authority receives the application.