Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

REACH – How does it affect the pharmaceutical industry? Consideration of the issue for a medium-sized enterprise ***

Dr. Ursula Beikert, (geb. Tammler) (Abschlußjahr: 2008)

Language: English

At June 1st 2007 Regulation (EC) No 1907/2006 came into force. The regulation is also called REACH regulation, whereas REACH means Registration, Evaluation, Authorisation and Restriction of Chemicals. It stands for a complete revision of the European chemicals legislation. Many directives and regulations concerning chemical substances and preparations are modified or overruled. Until then there were two classes of chemicals: 97% of substances for which nearly no data on risk for human health and the environment was provided and 3% of substances, which were evaluated regarding their risks. Now with the REACH regulation the requirements for all chemicals are harmonized, whereas transition periods till 2018 are provided.

The regulation describes a registration procedure for chemical substances, substances used in preparations or substances, which are part of an article. The registrant has to submit a dossier at the ECHA (=European Chemicals Agency), whose extent depends on the hazardousness of the substance and the annual quantity manufactured or imported. If he wants to take the transition period he additionally has to pre-registrate the substance and work together with other registrants of the same substance in a SIEF (=Substance Information Exchange Forum). The registration dossier is checked for completeness by the ECHA and a certain percentage of substances is also evaluated, mainly based on the documentation submitted. Dangerous substances have to be authorised by the ECHA before further marketing.

At first sight the pharmaceutical industry seems not to be affected by REACH, because substances used in human or veterinary medicinal products are exempted from the regulation. But there are several reasons for dealing with the subject, e.g.

  • Substances contained in the finished medicinal product are exempted from the regulation, whereas substances used during manufacture e.g. solvents for granulation or machine oil are concerned.
  • If substances are mainly used for other purposes e.g. in the automobile sector or the colouring industry, this quantity is still falling under the scope of the regulation. In the case that the manufacturer/importer doesnt want to deal with REACH and he also wont market the substance for pharmaceutical purposes only, the substance wont be available any longer.
  • Medical devices, which are often also part of a portfolio of a pharmaceutical company, have to fulfil the obligations of the regulation without exemption.


For a medium-sized enterprise without any own production facilities an approach for dealing with the REACH regulation and guarantee the further availability of substances is made. The activities recommended take place during the “pre-pre-registration” and the pre-registration as well as during the registration phase. Emphasis is given on a close cooperation between the supplier, the contract manufacturer and the marketing authorisation holder.

Pages: 45,
Annexes: 5 (5 pages)

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