That was stated at the Drug Regulation Course 2018, organized by the Bulgarian Association for Drug Information

The possibilities of parallel import to be a solution in the case of drug shortages and a sustainable partner in the drug supply chain were emphasized by Anton Manolev, Quality Assurance Manager at BestaMed at the Drug Regulation Course, organized by the Bulgarian Association for Drug Information. The manager in the largest parallel importer in our country was a representative of the Bulgarian Association for Medicines Parallel Trade Development.

The course on drug regulation was held on October 19th at the Forum Hotel in Sofia with the participation of 140 representatives of the regulatory bodies, the industry and the academical institutions. BAMPTD held a presentation on the topic “In search of a drug shortage solution”.

Anton Manolev presented the results of BAMPTD online survey for the period June – September 2018. In 53% of the cases, the solution lies in imports and fast intra-community supplies as the signals concern deregistered drugs, products with permanent or temporary discontinued imports into Bulgaria. Another main conclusion is that the lack of information accounts for 65% of the signals. 20% are the closed cases with information provided where the medicine is available, and in more than 60% the senders are directed to their physcian. Signals refer to a total of 120 products, indicating that 34% of them are regarding products with more than 1 signal. Each author has received feedback within 24 hours, and the average time to complete a case study is 32 hours.

The representative of BestaMed and BAMPTD has also explained the process of repackaging and labeling the medicinal products from parallel imports, which provides an additional guarantee of drug origin and safety.

Manolev explained that changes are needed in the Ordinance on the regulation and registration of medicinal products prices, namely to repeal the restrictive regime introduced in 2014, which is in contrary to the law and hinders imports at competitive prices and restricts patients’ access to medicines. In order to encourage the possibility of parallel distribution to give more public benefit, he recalled BAMPTD efforts to amend the Human Medicinal Products Act. The guidelines in which parallel distributors work, is to achieve understanding by the legislator in order to envisage licensing for imports of deregistered products for reasons unrelated to the drug safety and the regulation of rapid intra-community supplies.

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