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New import rules. Falsified Medicines Directive in force in Lithuania

Safety measures to prevent counterfeit medicines from reaching the consumer.

Medicines circulate between EU countries without restrictions. The active substances in counterfeit medicines may be of poor quality or their quantity may be too high or too low.

In order to prevent counterfeit medicinal products from entering the legal supply chain, the European Parliament and the Council of the European Union adopted Directive 2011/62 / EU on 8 June 2011, also known as the Falsified Medicines Directive (the Directive).

Under the Directive, active substances can only be imported if accompanied by written confirmation from the competent authority of the exporting country that the standards of good manufacturing practice and of control of the place of manufacture are equivalent to those in the EU.

Since 9 February, Regulation (EU) 2016/161 (the Regulation) laying down detailed rules for the implementation of safety measures for the packaging of human medicinal products and thus supplementing the Directive must be applied. It contains details on the security features and provisions on how and by whom the authenticity of medicines should be verified.

The outer packaging of prescription medicines other than those referred to in Annex I of the Regulation, as well as non-prescription medicines referred to in Annex II of the Regulation, must bear the following safety features: unique identifiers i.e., a two-dimensional bar code that allows the authenticity of a medicine to be checked and each individual packaging identified. The outer packaging of medicines must also bear an anti-tampering device in order to check whether the packaging of a medicinal product has been tampered with.

Before placing medicines on the market, pharma manufacturers and parallel importing companies must enter their unique identifier in the repositories system.

Wholesale distribution companies must check packaging safety measures in line with the procedure laid down in the Regulation based on risk assessment.

Pharmacies and health care institutions must check the anti-tampering device of each medicine before supplying it to consumers and deactivate the individual identifier in the national data storage system. For that purpose, access should be available to the national repository containing information on the unique identifiers of medicinal product packages placed on the market.

The Lithuanian Ministry of Health has prepared an order listing legal entities that need not log on to the national data storage system. In such a case, the authenticity of unique identifiers for the packaging of medicines must be checked by the medicines’ suppliers.

When implementing the Directive and the Regulation, a national medicines verification organization was established and a national Lithuanian medicines verification data storage and retrieval system was created to ensure unified protection of prescribed medicines in Lithuania.

Medicines manufactured and placed on the market before 9 February 2019 are not yet subject to current safety requirements and can remain on the market until their expiry date.