Conditions of requalification to medicinal product

(Issued by National Institute of Pharmacy)

1) Information for manufacturers and marketing authorization holders of paramedicinal healing products

According to the effective rules the manufacturers and marketing authorization holders can request for the requalification of the paramedicinal products to medicinal products, traditional herbal medicines or to other products until March 31, 2011. Requalification to medicine available without prescription or to traditional herbal medicine can be performed only if the requirements specified in the rules are met.

Attention! Each paramedicinal product registered at our Institute can only be marketed until April 1, 2011.

If you want to market your paramedicinal products with currently valid registration or marketing authorization after April 1, 2011, due to their medicinal effect, and therefore you intend to requalify them to medicinal products, please report your intention to our Institute, as preliminary information. In case of problems occurring in the course of compiling the documentation(s) it is possible to have personal consultation (after preliminary agreement).

2) Information for submitting the request for requalification to medicine (traditional herbal medicine, or other medicine available without prescription/herbal medicine)

2.1 For the evaluation of the (new) request for requalification you are requested to submit the documents in the following way:

- the European Commission: Notice to Applicants Volume 2B, Application Form, in three copies,

- the documentation supporting the application according to Subsection (1) of Section 7 of the Decree No. 52/2005 (XI.18) E??M (in case of medicines available without prescription) or Sections 10-13 (in case of traditional herbal medicine), according to the specification of Annex No. 1 in CTD (Common Technical Document) format,

- certificate of payment,

- additional important information about the details of compiling the dossier can be found in Chapter 1, Chapter 7 of Notice to Applicants Volume 2A (number of copies, national characteristics, etc.).