Applications for renewal of marketing authorizations for Pharmaceuticals and Biological products for veterinary use, expiring 31.12.2009
We inform you that the applications of interested parties for the renewal of the marketing authorization for proprietary medicinal products and biological products for veterinary use have expired. 31.12.2009 will be accepted at the Veterinary Department of the Product Evaluation Department of the Hellenic Food and Drug Administration during the period from 1.6.2009 until 26.6.2009 and during the hours 8.30 a.m. to 11.30 a.m.
The exact date on which applications will be submitted for each company is indicated in attached ANNEX.
A. DOCUMENTATION FOR MEDICINAL PRODUCTS FOR ANIMAL USE
1. Renewal application. One application separately for each pharmaceutical form and/or strength (the form can be found on the EOF website www.eof.gr).
2. Summary of product characteristics (SPC) (or proposed for products that do not have an SPC) in accordance with attachment 1.
3. Inner and outer packaging and package leaflet according to attachment 1.
4. Photocopy of the valid production permit, from the last five years.
5. A photocopy of the latest marketing authorization with the current SPC, Labels and VAT attached, as well as any amendment to the authorization. For products for which a renewal decision has been issued that does not contain all the product information, the previous authorization or renewal decision will also be submitted.
6. Copy of the Ministry of Development (Trade Sector) seal.
7. Fee 1500 + 2,4% Euro per product.
8. Periodic safety update reports (PSURs) for each product for the last five years.
9. Declaration that documentation of the withdrawal period has been submitted for products intended for food-producing animals and provided that the active substance(s) has/have been included in Table I of Regulation 2377/90.
10. Summary evaluation report on quality, safety and efficacy.
11. Declaration of the qualified person of article 50 (f) of Ministerial Decision 282371/Government Gazette 731//Β΄/16.6.2006 as amended that the production of the raw materials used for the production of the veterinary product is in accordance with the guidelines of good manufacturing practice.
formulation practice of raw materials.
12. Declaration on TSE for those products whose composition contains material of bovine or more generally animal origin in accordance with the relevant guideline.
B. DOCUMENTATION FOR ORGANIC PRODUCTS FOR VETERINARY USE
In addition to the supporting documents in case A, for organic products, the special form (pages 4-5 of this document) will also be submitted, completed.
ATTENTION:
Interested parties are kindly requested to note the following:
a. In the renewal application no modification request should be included any element of the license.
b. During the renewal submission period, a written statement from the responsible parties regarding the non-renewal of the marketing authorization of the products (forms, strengths or packaging) whose renewal is not desired. EOF will proceed to the principles of 2010 to the revocation of these marketing authorizations (relevant forms are attached, pages 6-7).
c. The obligation to submit renewal applications within the specified deadline is independent of whether or not a previous renewal decision has been issued.
In the event of failure to submit a renewal application, the current provisions prohibiting the circulation of these products will apply.
d. The above supporting documents must be submitted to hard separate plastic folders for each format - content of appropriate thickness for their best technical arrangement in the EOF Archive.
e. The amount of the fee is 1500+2,4% euros, per product. The fee must be deposited with the Bank of Greece (account no. 26303/8).
f. For all products for which marketing authorizations have been issued "exclusively for export» which expire on 31-12-2009, interested parties should contact the Production & Product Circulation Control Department.
Finally, within the framework of good cooperation, we ask all interested parties to correctly and completely complete the required information and supporting documents.
Deficiencies and errors lead to delays and inconveniences for both the interested parties and the services that check the data and process the issuance of the relevant permits.
The Veterinary Department remains at the disposal of interested parties for relevant clarifications and explanations.
THE PRESIDENT of EOF
KING KONTOZAMANIS
Download it attachment 1.
