Opponents of the bill, which included some labor unions and pharmacists, contended that once the F.D.A. had declared a biosimilar interchangeable with the original product, notification of doctors and patients was unnecessary and would only raise doubts about the safety of biosimilars and discourage their use.
Opponents of the bill contended that once the F.D.A. had declared a biosimilar interchangeable with the original product, notification of doctors and patients was unnecessary and would only raise doubts about the safety of biosimilars and discourage their use, they said.
The new Plant Protection Products Regulation does not contain such an article on product notification, and thus article 45 on product notification of the CLP Regulation, as a 'general legislation' on substances and mixtures, applies directly to this product group.
It provided a good basis for further discussion between all stakeholders to harmonise product notification in EU Member States.
The forthcoming Biocidal Products Regulation (expected in 2011) will contain an article on product notification referring to article 45 of the CLP Regulation.
9 After two more meetings on this matter the EC will report (before January 20 , 2012 whether harmonisation of product notification can be reached, and how.
For companies it would be most convenient if the well-established Safety Data Sheet SDSS) that must be available for hazardous mixtures could be used for product notification.
In the discussions on the harmonisation of product notification, this extended and improved SDS is foreseen to be part of the notified product information to PCs and is currently already used for this purpose in several EU Member States.
The European Commission (COM) may request an opinion from the 'Scientific Committee on Consumer Safety' (SCCS) in case of safety concerns about the respective product notification or the particular NM used in the cosmetic product.
At a late stage in the development of the CLP Regulation, under the pressure of all stakeholders (EAPCCT, governmental authorities, industry), this shortcoming was recognised and corrected with paragraph 4. It states that, before January 20 , 2012 the EC shall review the possibility to harmonise product notification to the appointed bodies in the EU, including establishing a data exchange format.
