Hungary: requalification of therapeutic products

Manufacturers and distributors have until 31 March 2011 to requalify their therapeutic products. This means that, from 1 April 2011, any therapeutic product that has not undergone the requalification process may no longer be distributed.

The marketing authorisation must be obtained from the National Institute of Pharmacy and will allow therapeutic products to be distributed as either non-prescription medicines or traditional herbal medicines.

The benefits of the requalification process are:

• it is much quicker and simpler than having to obtain marketing authorisation from scratch
• it can be done on the basis of documentation submitted for the therapeutic product’s original registration
• there is no need for manufacturers and distributors to stop distributing the product while the requalification process is ongoing
• the NIP provides support for companies seeking to requalify their products, including personal consultation on issues about the compilation of documents

To allow for delay and ensure continuity of distribution, the requalification process should be begun as soon as possible. All documents included in applications must be submitted in the common technical document (CTD) format.

To requalify a product as a non-prescription medicine, applicants must show 10 years’ well established medicinal use within the EEA of its constituents or active ingredients, with recognised efficacy and an acceptable level of safety.

To requalify a product as a traditional herbal medicine, applicants must show that:

• by virtue of their composition and purpose, the products are intended and designed for use without medical supervision for the purpose of diagnosis, prescription or monitoring treatment
• they are to be applied orally, externally and/or by inhalation
• its efficacy can be established from bibliographical or expert evidence, or a corresponding product has been in continuous medicinal use for at least 30 years before the application date, including at least 15 years within the EU