http://www.legislation.gov.uk/uksi/2013/1855/regulation/13/made
The Human Medicines (Amendment) Regulations 2013
en
King's Printer of Acts of Parliament
2017-07-24
MEDICINES
These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”) in order to implement—Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (“Directive 2011/62/EU”);Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (“the Implementing Regulation”);an EU Corrigendum which corrects an error in Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicines for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products (“the EU Corrigendum).
PART 2Amendment of the Human Medicines Regulations 2012
Amendment of regulation 4213
In regulation 42 (conditions for wholesale dealer’s licence), for paragraph (2) substitute—
2
Those provisions are regulations 43(2) and (8) and 44.