1. Articles 5, 6, 7, 17, 18 and 21 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.
L 396/68 EN Official Journal of the European Union 30.12.2006
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.
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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 programme.
8. The Agency shall forthwith communicate any draft decisions to the competent authorities
of each Member State in which the manufacture, import, 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, 92 and 93, against Agency
decisions under paragraphs 4 and 7 of this Article.
