Annex 10

(Art. 14 para. 2 let. c)

Application for authorisation for parallel trade

1 Documents for applications under Article 7 paragraph 1 letter j number 1

1.1 The application for authorisation for parallel trade must contain the following information:

1. name and authorisation number of the biocidal product in the country of origin;
2. name and address of the competent authority of the country of origin;
3. name and address of the authorisation holder in the country of origin;
4. original label and instructions for use with which the biocidal product is placed on the market in the country of origin, if this is considered by the Notification Authority to be necessary for the evaluation;
5. name and address of the applicant;
6. name to be given to the biocidal product which is to be placed on the market;
7. a draft label for the biocidal product intended to be placed on the market, in two official languages;
8. a sample of the biocidal product which is to be imported, if this is considered necessary by the Notification Authority;
9. name and authorisation number of the reference product.

1.2 The Notification Authority may require a translation of the relevant parts of the original instructions for use referred to in paragraph 1 letter d.

2 Documents for applications under Article 7 paragraph 1 letter j number 2

2.1 The application for authorisation for parallel trade under Article 7 paragraph 1 letter j number 2 must include the following information:

1. the name of the biocidal product;
2. the information set out in number 1 letters d–i.

2.2 The Notification Authority may request the applicant to provide the following:

a. a translation of the essential parts of the original instructions for use mentioned in number 1.1 letter d; and

b. additional documents to establish that the biocidal product is identical to the reference product.