In 2023, the pharmaceutical market in Bulgaria is expected to grow at a significant growth rate of just over 14%. Alongside the key role of the pharmaceutical industry, the regulation of relations affecting the trade in medicinal products is also important to ensure the protection of citizens’ health.
One of the key elements in the regulation of the pharmaceutical sector is the marketing authorization for wholesale of medicinal products. The purpose of this article is to summarize the requirements for and the main elements of the procedure for granting this marketing authorization.
Regulation
The requirements for obtaining marketing authorization for wholesale of medicinal products are mainly regulated by the Medicinal Products in Human Medicine Act (MPHMA) and Regulation No. 39 of 13 September 2007 on the principles and requirements for Good Distribution Practice (GDP).
Who issues the authorization?
In Bulgaria, the marketing authorization for wholesale of medicinal products is issued by the Bulgarian Drug Agency (BDA).
Who can obtain marketing authorization?
Both natural and legal persons can be granted marketing authorization as long as they meet the legal requirements.
Requirements for the applicant
A person wishing to obtain marketing authorization for wholesale of medicinal products shall ensure that a number of conditions are met:
- Suitable storage premises
The applicant shall provide storage facilities that meet the standards of Good Distribution Practice. Specific requirements are laid down regarding floor space, temperature, humidity, isolation from other products, etc.
On-the-spot inspections shall be carried out by the BDA authorities to verify that all the requirements concerning the premises are met.
- Responsible Master Pharmacist
A qualified manager of the activity and of the storage premises is required. The manager must be a Master Pharmacist who has at least 2 years’ experience in the specialty, be a member of the Regional Pharmaceutical Association as per the location of the warehouse to be used for the storage of medicinal products, be employed by the applicant`s company and not be an employee of another company.
How does the procedure work?
The marketing authorization procedure starts with an application form, which is submitted to the BDA. The application may be submitted either by the person wishing to obtain marketing authorization for wholesale or by their proxy.
The application must be accompanied by specific documents, including:
- Documents certifying the legal basis for the use of the storage premises, such as a lease agreement;
- Documents certifying compliance with the requirements for a Master Pharmacist, including: diploma; employment contract; proof of employment; criminal record;
- Proof of payment of the state fee.
Within 14 days of the submission of the application, an inspector from the BDA shall make an initial inspection of the documentation submitted. If the documentation is compliant, a second inspection shall be ordered. The second inspection shall be an on-the-spot inspection to establish whether the actual storage and operating conditions comply with the documentation submitted and the requirements of Good Distribution Practice (GDP).
The results of the inspection shall be documented in a report to be drawn up within 5 days of the inspection. Where the documentation and the requirements of the GMP are met, the inspector shall prepare a proposal and a draft of the marketing authorization for wholesale of medicinal products and the marketing authorization for wholesale of medicinal products shall then be issued.
Fees
Pursuant to Article 16, para. 1 of the Tariff of Fees to be collected under the MPHM Act, the fee is BGN 7,500, which is payable to the BDA.
Validity of the authorization. The marketing authorization for wholesale of medicinal products shall be of unlimited duration. In the event of changes in the circumstances of the issued Marketing Authorization, the holder of the Marketing Authorization is obliged to declare the changes pursuant to Article 206 of the MPHM Act. The Marketing Authorization for wholesale of medicinal products shall be terminated if the holder so requests in writing from the Executive Director of the BDA. In the event of non-compliance with the conditions under which the Marketing Authorization for wholesale of medicinal products was granted, the Executive Director of the BDA shall issue an order for its revocation (Article 293(2) and (5)).
