Who can carry out wholesale trade with medicinal products?
⊶ A natural or legal person holding a permit for wholesale trade in medicinal products, issued by a regulatory authority in the relevant
⊶ EU member state and having storage facilities on the territory of the Republic of Bulgaria;
⊶ A natural or legal entity registered under the Law on the Commercial Register, having storage facilities on the territory of the Republic of Bulgaria.
Premises requirements
The person carrying out wholesale trade in medicinal products must have suitable premises, equipment and facilities, as well as suitable means of transport, ensuring the correct storage, distribution and transportation of medicinal products, in accordance with the requirements of the Good Distribution Practice.
a
Personnel requirements
The wholesaler of medicinal products must have qualified staff and a responsible master pharmacist with at least two years of work experience in the specialty, for whom he can present:
⊶ Criminal record certificate – original or notarized copy;
⊶ Work experience document;
⊶ Higher education diploma – notarized copy;
⊶ Certified copy of the employment contract.
b
Competent authority
Medicines Executive Agency (MEA)
c
Procedure
The procedure starts with the submission of an application together with the necessary documents to the IAL, which evaluates the documentation and performs an on-site inspection.
Within 90 days from the date of submission of the application, the executive director of IAL issues a wholesale trade permit or makes a reasoned refusal.
The issued authorization for wholesale trade in medicinal products is indefinite.
d
Cost
For issuing and evaluating the documentation about getting a permit for wholesale trade in medicinal products, the cost is BGN 7,500.
The procedure for wholesale trade in medicinal products does not include products containing narcotic substances. The latter are subject to a more special permit regime.
What the Lead Consult LTD team does for you:
✔ Registration of a company LLC/LTD/JCS
✔ Preparation of an application and all necessary documents for wholesale trade in medicinal products
✔ Submission of the documents to the MEA and follow-up of the entire procedure
✔ Obtaining the issued permit
The Lead Consult team offers you professional services and consultation. Please contact us at:
☎ phone + 3598 888 33 600
✉ email: office@leadconsult-bg.com