The interim period for borderline products will expire on 31 December 2009 after attempts to extend it failed.
The interim period applies to products that:
- were placed on the market in Poland before 1 May 2007
- satisfied the criteria of medicinal products and other product categories (such as dietary supplements) on the day they were placed on the market
The expiry of the interim period has no official interpretation. In particular, it is not clear if borderline products could be placed on the market after 31 December 2009 or must be withdrawn from the market after this date.
As there are no clear criteria for distinguishing between borderline and medicinal products (in particular with regard to herbal products) an analysis of individual products is necessary.
Where there are doubts whether a borderline product meets the criteria for medicinal products, this would be made in the course of clearance proceedings conducted by the sanitary inspection.
This means that, where the interim period applies, there is no basis for withdrawing borderline products from the market without an assessment.
Where a product is shown in clearance proceedings to meet the criteria for medicinal products, it will be withdrawn from the market subject to a right of appeal by the business responsible for putting it on the market.
This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 30/12/2009.
