The Medical Devices in Human Medicine Act (the “Act”) clarifies the provisions regarding jointly-coordinated control proceedings over drugs to be conducted between the Bulgarian Drug Agency (the “BDA”) and the regional health inspectorates. A new drugs tracking mechanism has been introduced. The old systems for electronic data transfer are replaced by unique national identification numbers generated by the BDA to identify every medical device. The purpose of this number is to provide unambiguous identification of each medical product at the market and is mainly applied for the preparation of medical documentation regarding drugs.
There are amendments regarding the documents that should be presented to the BDA by the holder of the respective permit prior to the placement of batches of the following medical devices on the market:
- immunological medical devices, designed for immunization;
- medical devices incorporating stable derivatives of human blood or human plasma.
In compliance with the European legal framework the amendments provide that the samples and protocols for the production and quality control of all batches should comply with the data indicated in the World Health Organisation Manual for Batch Release by national regulatory authorities.
During the verification procedure preceding the placement of batches on the market the BDA may conduct additional tests of the drug samples if there are significant changes or deviations, regarding:
- the production process;
- the place of production;
- the results of the quality tests carried out by the manufacturer or the official regulatory authority, etc.
Before the adoption of the Act the regulation of certification procedures for batch release has been provided for in an ordinance. Now, the Act provides that this certificate may be issued prior to the placement of the batch on foreign markets by the Executive Director of the BDA, as well. In addition, at the choice of the applicant, the certificate can be issued either in Bulgarian, or in English language.