It also led to the invocation of national safeguard clause measures or emergency measures under Article 23 of Directive 2001/18/EC and Article 34 of Regulation (EC) 1829/2003, respectively.
In accordance to directive 2008/57/EC the railway companies must verify this at least in context to the conferral and monitoring of safety authorization based upon article 11 of directive 2004/49/EC [6] and for licensing and supervision of safety certification based upon article 10 of directive 2004/49/EC.
PPPs and biocidal products are collectively denoted as 'pesticides' under EU law, as has been defined in Article 3 of Directive 2009/128/EC on the sustainable use of pesticides in the European Community (EC) [[4]].
These exemptions can be derived from the definitions in Article 3 of Directive 2001/83 (The European Parliament and the Council of the European Union 2001), the so called magistral and officinal formulae.
In the European Union, the general provision on food origin labelling is set by Article 3 of Directive 2000/13/EC (Directive 2000): the indication of the place of origin or provenance is mandatory if the omission of such information might mislead the consumer.
In Europe a biosimilar product is reviewed after a similar biological application as per Article 10(4) of directive 2001/83/EC 17.
In 2007, the European Commission requested a referral to the Committee for Medicinal Products for Human Use CHMPP) under Article 31 of Directive 2001/83/EC, as amended, for MPH because of safety concerns [ 5].
Further, the Commission shall, if appropriate, make proposals to improve the readability, layout and content of these documents involving relevant stakeholders (article 59(4) of Directive 2001/83/EC, as amended).
Given this, it is intuitive that MAA cannot be filed under Article 10(1) of Directive 2001/83/EC (generic application) which would be entailed with formal demonstration of bioequivalence.
Sows and gilts need to be kept in groups from 4 weeks after service to 1 week before the expected time of farrowing (Article 3(4) of Directive 2008/120/EC on the protection of pigs).
In 2009, the results of a full risk: benefit assessment of methylphenidate-containing medications by the EMA's Committee for Medicinal Products for Human Use CHMPP) under Article 31 of Directive 2001/83/EC (amended) was published.
