# Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed), Division 5.1.2: Medical surveillance on manufacturing plant personnel

Extent: E+W+S+N.I.

Available reports of occupational health surveillance programmes, supported with detailed information on the design of the programme and on exposure to the micro-organism must be submitted. Such reports should, where feasible, include data relevant to the mechanism of action of the micro-organism. These reports shall, where available, include data from persons exposed in manufacturing plants or after application of the micro-organism (e.g. in efficacy trials).
Special attention shall be devoted to those whose susceptibility may be affected, e.g. pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.

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Source: https://www.legislation.gov.uk/eur/2011/544/annex/part/B/division/5/division/2/division/5.1/division/5.1.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-544/annex/part-B/division-5/division-2/division-5.1/division-5.1.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.