According to Article 2(5)(a) of the REACH Regulation substances used in
medicinal products for human or veterinary use within the scope of the
relevant Community legislation are exempted from the Registration Title of the
REACH Regulation (Title II). More explanation is provided for in section
220.127.116.11 of the Guidance on Registration available at the ECHA website:
Substances fulfilling the conditions of Article 2(5)(a) of the REACH Regulation
are also exempt from the Titles on Downstream Users, Evaluation and
Authorisation (Titles V, VI and VII of the Regulation).
Importantly, substances are exempted from these Titles only to the extent that
they are used in medicinal products in accordance with Regulation 726/2004,
Directive 2001/82 and Directive 2001/83. Quantities of the same substance
used for other purposes are not exempted.
The exemption covers the manufacture (in the EU) of substances in medicinal
products that are exported; and the manufacture (in the EU) of active
substances within the scope of Community legislation on medicinal products
that are exported. The exemption also applies to imports of substances in
medicinal products and imports of active substances within the scope of the
Community rules on medicinal products.
Intermediates that are not present in the medicinal product (as defined in
Regulation 726/2004, Directive 2001/82 and Directive 2001/83) are not
exempted from registration.
แหล่งที่มา :ECHA_FAQ_version 2.3_2008-11-06
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