Czech Republic: EU accession - pharmaceutical

What changes have already been made to Czech pharmaceutical law?

New measures have been passed which are aimed at bringing Czech law into line with EU requirements. Some of the new regulations include:

• the introduction of new requirements for registering medicinal products, including areas such as marketing authorisation applications and clinical trials
• the establishment of a data exclusivity period, protecting producers of original products from references to their original dossiers, for six-years from registration in the Czech Republic or first registration in the EU
• new requirements for the documentation of generic applications
• new detailed requirements for clinical trials of medicinal products for human use
• the introduction of new regulations for the manufacturers of medicinal products, including regulations on manufacturing licences and certifications of manufacturers of medical substances
• the introduction of new regulations on the wholesale distribution of medicinal products
• the establishment of new limitations on advertising medicinal products, including new regulations on advertising to professionals and the public
• the introduction of new regulations specifying the rights of the appropriate authorities in the Czech Republic; and
• the introduction of new penal sanctions for violating provisions of the Pharmaceutical Law.

What changes to Czech pharmaceutical law come into effect on accession?

The major changes that are to come into force on the date of Czech accession to the EU include:

• the recognition of registration granted by European Union bodies under a centralised procedure in accordance with the Council Directive 2309/93
• data exclusivity as defined by Directive 2001/83 of 10 years after authorising a highly innovative product on the market in the EU; the data exclusivity period of 6 years protecting producers of original products from references to their original dossiers from registration in the Czech Republic or the first registration in the EU is currently effective and was introduced prior to the current amendment made by the Act No. 129/2003
• a mutual recognition procedure resulting in the suspension of Czech registration proceedings until a decision has been reached in a prior case before another EU registration office and the recognition of such a decision
• a specific procedure of permitting the parallel import to the Czech Republic of pharmaceutical products. Although such specific permitting procedure in respect of parallel imports is not part of EU legislation, due to the fact that this issue is dealt with by numerous decisions of the European court, the Czech parliament intends to introduce statutory rules with the aim of preventing uncontrollable parallel imports to the Czech Republic
• the applicability of the EU Directive 141/2000 on medicines for rare diseases, whereby the medicines and their registration of rare diseases is subject to this Directive
• the introduction of provisions relating to good clinical practice and the clinical valuation of human medicines. The provisions have been drafted to comply with Directive 2001/20/EC; in this respect the Act 129/2003 Coll would also introduce a new regulation in respect of ethical committees, and a mechanism to allow the ethical commissions to create a joint statement in the Czech Republic in respect of clinical valuation
• the recognition of rights of distributors who received an authorisation to distribute in another member state of the EU, and the introduction of a notification duty of such EU member states authorised distributors to the Czech authorities.

What can you do to ensure you comply with the new law and prepare for accession?

Different types of entities should implement different steps to ensure that they are prepared for the existing and coming changes; in particular, you should make sure that:

• your products which are authorised in the Czech Republic are held by a Czech or an EU-based entity
• you are authorised to produce medicinal products in the Czech Republic or have a foreign good manufacturing practice (GMP) recognised by the authorised bodies in the Czech Republic
• you are authorised to advertise medicinal products, control methods of advertising of your products and adjust your advertising activity to the new requirements; and
• your regulatory dossier is in compliance with EU requirements.

Future developments

Proposed European Regulation and Directives relating to medicinal products are currently being considered in the European Parliament. If these are adopted, further changes will need to be made to national legislation to bring it into compliance.

For further information please contact Hilary McDowell.