PART 8SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS – AMENDMENTS TO REGULATION (EC) No 469/2009

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1

Article 1 (interpretation) is amended as follows.

2

In paragraph (e) for “Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use”, substitute “regulation 58A(3) of the Human Medicines Regulations 20126”.

3

After paragraph (e) insert—

f

‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;

g

‘court’ is to be interpreted in accordance with Article 1A;

h

“EEA authorisation” means an authorisation to place a medicinal product on the market which has effect in an EEA state in accordance with Directive 2001/83/EC or Directive 2001/82/EC;

i

‘patent’ means a patent which has effect in the United Kingdom;

j

‘UK authorisation’ means, in relation to a product, an authorisation to place that product on the market as a medicinal product granted in accordance with—

i

Part 5 of the Human Medicines Regulations 2012; or

ii

regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations 20137.