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1. Articles 5
shall not apply for a period of five years to a substance manufactured in the Community or imported for the purposes of product
and process orientated research and development
by a manufacturer or importer
or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose
of product and process orientated research and development
2. For the purpose of paragraph 1, the manufacturer or importer
or producer of articles shall notify the Agency
of the following information:
(a) the identity of the manufacturer or importer
or producer of articles as specified in section 1 of Annex VI
(b) the identity of the substance, as specified in section 2 of Annex VI
(c) the classification of the substance as specified in section 4 of Annex VI
, if any;
(d) the estimated quantity as specified in section 3.1 of Annex VI
(e) the list of customers referred to in paragraph 1, including their names and addresses.
The notification shall be accompanied by the fee required in accordance with Title IX.
The period set out in paragraph 1 shall begin at receipt of the notification at the Agency
3. The Agency
shall check the completeness of the information supplied by the notifier and Article 20
(2) shall apply adapted as necessary. The Agency
shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification
at the Agency
, and shall forthwith communicate that number and date to the manufacturer, or importer
, or producer of articles concerned. The Agency
shall also communicate this information to the competent authority of the Member State(s) concerned.
4. The Agency
may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance
is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(e) in reasonably controlled
conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will
not be made available to the general public at any time either on its own or in a preparation or article and that remaining
quantities will be re-collected for disposal after the exemption period.
In such cases, the Agency
may ask the notifier to provide additional necessary information.
5. In the absence of any indication to the contrary, the manufacturer or importer
of the substance or the producer or importer
of articles may manufacture or import
the substance or produce or import
the articles not earlier than two weeks after the notification.
6. The manufacturer or importer
or producer of articles shall comply with any conditions imposed by the Agency
in accordance with paragraph 4.
7. The Agency
may decide to extend the five-year exemption period by a further maximum of five years or, in the case of substances
to be used exclusively in the development of medicinal products for human or veterinary use, or for substances
that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer
or producer of articles can demonstrate that such an extension is justified by the research and development
8. The Agency
shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture,
, production or product and process orientated research takes place.
When taking decisions as provided for in paragraphs 4 and 7, the Agency
shall take into account any comments made by such competent authorities.
9. The Agency
and the competent authorities of the Member States
concerned shall always keep confidential the information submitted in accordance with paragraphs 1 to 8.
10. An appeal may be brought, in accordance with Articles 91
, against Agency
decisions under paragraphs 4 and 7 of this Article.