Directive 2001/83/EC of the European Parliament and of the CouncilDangos y teitl llawn

Article 114 U.K.

1. Where it considers it necessary in the interests of public health, a Member State may require the holder of an authorization for marketing:

• live vaccines,

• immunological medicinal products used in the primary immunization of infants or of other groups at risk,

• immunological medicinal products used in public health immunization programmes,

• new immunological medicinal products or immunological medicinal products manufactured using new or altered kinds of technology or new for a particular manufacturer, during a transitional period normally specified in the marketing authorization,

to submit samples from each batch of the bulk and/or the medicinal product for examination [F1 by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose] before release on to the market unless, in the case of a batch manufactured in another Member State, the competent authority of that Member State has previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples.

2. Where, in the interests of public health, the laws of a Member State so provide, the competent authorities may require the marketing authorization holder for medicinal products derived from human blood or human plasma to submit samples from each batch of the bulk and/or the medicinal product for testing [F1 by an Official Medicines Control Laboratory or a laboratory that a Member State has designated for that purpose] before being released into free circulation, unless the competent authorities of another Member State have previously examined the batch in question and declared it to be in conformity with the approved specifications. Member States shall ensure that any such examination is completed within 60 days of the receipt of the samples.

Textual Amendments

F1 Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.