1. A plant protection product that is authorised in one Member State (Member State of origin) may, subject to granting a parallel trade permit, be introduced, placed on the market or used in another Member State (Member State of introduction), if this Member State determines that the plant protection product is identical in composition to a plant protection product already authorised in its territory (reference product). The application shall be submitted to the competent authority of the Member State of introduction.
2. From receiving a complete application, a parallel trade permit shall be granted in a simplified procedure within 45 working days if the plant protection product to be introduced is identical in terms of paragraph 3. Member States shall on request provide each other with the information necessary to assess whether the products are identical within 10 working days of receiving the request. The procedure for granting a parallel trade permit is interrupted from the day the request for information is sent to the competent authority of the Member State of origin until the complete information required is delivered to the competent authority of the Member State of introduction.
3. Plant protection products shall be considered as identical to the reference products if:
(a)
they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;
(b)
they are identical in specification and content to the active substances, safeners and synergists, and in the type of formulation; and
(c)
they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
4. The application for a parallel trade permit shall include the following information:
(a)
the name and registration number of the plant protection product in the Member State of origin;
(b)
the Member State of origin;
(c)
the name and address of the authorisation holder in the Member State of origin;
(d)
the original label and instructions for use with which the plant protection product to be introduced is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction. This competent authority may require a translation of the relevant parts of the original instructions for use;
(e)
the name and address of the applicant;
(f)
the name to be given to the plant protection product to be distributed in the Member State of introduction;
(g)
a draft label for the product intended to be placed on the market;
(h)
a sample of the product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction;
(i)
the name and registration number of the reference product.
The information requirements may be amended or completed and further details and specific requirements shall be established in cases of application for a plant protection product for which a parallel trade permit has already been granted and in cases of an application for a plant protection product for a personal use in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
5. A plant protection product for which a parallel trade permit has been issued shall be placed on the market and used only in accordance with the provisions of the authorisation of the reference product. To facilitate monitoring and controls the Commission shall set out specific control requirements for the product to be introduced in a Regulation referred to in Article 68.
6. The parallel trade permit shall be valid for the duration of authorisation of the reference product. If the authorisation holder of the reference product applies for a withdrawal of authorisation in accordance with Article 45(1) and the requirements of Article 29 are still fulfilled, the validity of the parallel trade permit shall expire by the date on which the authorisation of the reference product would normally have expired.
7. Without prejudice to specific provisions of this Article, Articles 44, 45, 46, and 55 and Article 56(4) and Chapters VI to X shall apply to parallel traded plant protection products correspondingly.
8. Without prejudice to Article 44, a parallel trade permit may be withdrawn if the authorisation of the introduced plant protection product is withdrawn in the Member State of origin because of safety or efficacy reasons.
9. Where the product is not identical, in terms of paragraph 3, to the reference product, the Member State of introduction may only grant the authorisation required for placing on the market and use in accordance with Article 29.
10. The provisions of this Article shall not apply to plant protection products which are authorised in the Member State of origin in accordance with Article 53 or 54.
11. Without prejudice to Article 63, Member State authorities shall make publicly available information about parallel trade permits.
Subsection 6
Derogations