Paramedicine again

At the beginning of January 2011 a new modification of the 2005 Medicinal Act came into force:

According to the last year’s version (see Important news: Conditions of requalification to medicinal product) paramedicinal healing products were allowed to market till 1st April 2011.

By the new version of the law all products containing herbal components can be sold till 1stApril 2013 without upgrading while marketing of paramedicines not containing herbals is not limited in time.

This change brought relief to many companies who were not able to present registration documentations according to pharmaceutical standards (and the cost!) but was a bit unfair to many other firms who took the last years regulation seriously and concentrated all efforts and financial possibilities to apply for pharmaceutical category.

See the relevant section of the law published on the homepage of National Institute of Pharmacy:

Information about the requalification of the paramedicinal substances and products not qualified as medicines

Since January 11, 2011, the following act replaces Subsections (7) and (9) of Section 32 of Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products:

54. § „(7) Based on the Ministerial Decree about the registration and marketing of paramedicinal substances and products not qualified as medicines, manufacturers and distributors of paramedicinal substances and products not qualified as medicines may ask for the requalification of their products containing herbal components too, to medicine or other product, until March 31, 2011. Following the entry into force of this Act, procedure cannot be initiated for the registration and marketing of a paramedicinal product not qualified as medicine.”

54. § „(9) The paramedicinal substances and products not qualified as medicines, containing herbal component too, which are on the market on March 31, 2011, can be marketed until their expiry date, but until April 1, 2013, at the latest, referring to their therapeutic effect.”

On the basis of the above, our dear Customers are informed about the following:

Following January 1, 2011 procedure cannot be initiated at the National Institute of Pharmacy for the registration and marketing of a new product registered as paramedicinal substance or product not qualified as medicine (hereinunder paramedicinal product)

Based on Subsection (1) of Section (2) of the Decree 53/2005 (XI.18)  of the Minister of Health about the conditions of the requalification of  paramedicinal substances and products not qualified as medicines to medicines for human use (hereinunder: Decree about the requalification) paramedicinal product can be requalified to medicine or traditional herbal medicine, that can be issued without prescription.

Authorization

Manufacturers or distributors of paramedicinal products containing only herbal components, or containing herbal components too, can apply for the requalification of their products to medicine, or to another product. Following March 31, 2011, these products cannot be marketed as medicines with requalification, but according to the authorization rules of the Decree 52/2005 (XI.18)  of the Minister of Health about the marketing of medicines for human use (hereinunder: Decree 52), i.e. with a new authorization procedure. Therefore, following March 31, 2011 the following are not effective

·        the regulation facilitating the registration of the Decree about the requalification, and

·        the fee more favourable than that of the procedure for the authorization of the medicinal products, defined in the Pharma Law.

Of course, manufacturers or distributors of the paramedicinal products not containing herbal component may also apply for the requalification of their products, without time-limit. Therefore the following are valid without time-limit:

·        the regulation facilitating the registration of the Decree about the requalification, and

·        the fee more favourable than that of the procedure for the authorization of the medicinal products, defined in the Pharma Law.

Marketing

Your attention is called, that the paramedicinal products containing exclusively herbal components, or contain herbal components too, can be marketed until their expiry date, but until April 1, 2013, at the latest, referring to their therapeutic effect.

The paramedicinal products not containing herbal component can be marketed without time limit, even after April 1, 2013 in this product category. But the rules relating to manufacturing, extension of the registration and marketing of the paramedicinal substances and products not qualified as medicines, defined in Decree 10/1987 (VIII.19.) of the Minister of Health about registration and marketing of the paramedicinal substances and products not qualified as medicines, continue to be effective.

Dear Customers, please be informed that the NIP is ready for consultation in relation of the requalification of the paramedicinal products.