Article 8 Content of the application for a certificate

a request for the grant of a certificate, stating in particular:

1. (i)

   the name and address of the applicant;

2. (ii)

   if F1the applicant has appointed a representative, the name and address of the representative;

3. (iii)

   the number of the basic patent and the title of the invention;

4. (iv)

   F2 the number and date of the UK, GB or NI authorisation, or where there is more than one such authorisation, of each authorisation as referred to in Article 3(b) and (d);

5. (v)

   the number and date of the earliest of any EEA authorisation, the granting of which predates the granting of the UK , GB or NI authorisation as referred to in Article 3(b) and (d);

a copy of the UK, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation to place the product on the market, as referred to in Article 3(b) and (d), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC, Article 14 of Directive 2001/82/EC, F4Article 35 of Regulation (EU) 2019/6, Part 2 to Schedule 8 of the Human Medicines Regulations 2012 or Part 1 of Schedule 1 to the Veterinary Medicines Regulations 2013;

where the product is the subject of one or more EEA authorisations granted prior to the UK, GB or NI authorisation referred to in Article 3(b) and (d), the applicant must provide in relation to the earliest of any such EEA authorisations—

where the application for a certificate includes a request for an extension of the duration:

1. (i)

   a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in F5regulation 58A(2)(a) of the Human Medicines Regulations 2012;

2. (ii)

   F6details of the territory in respect of which the statement referred to in sub-paragraph (i) has been made.