Article 22

1. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 21, without prejudice to his relationship with the holder of the authorization referred to in Article 16, is responsible, in the context of the procedures referred to in Article 25, for securing: (a) in the case of proprietary medicinal products manufactured within the Member States concerned that each batch of proprietary medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization; in the case of proprietary medicinal products coming from third countries, that each production batch has undergone in the importing country a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other tests or checks necessary to ensure the quality of proprietary medicinal products in accordance with the requirements of the marketing authorization. The batches of products which have undergone such controls in a Member State shall be exempt from the above controls if they are imported into another Member State, accompanied by the control reports signed by the qualified person. A Member State may relieve the qualified person of responsibility for the controls prescribed under (b) for imported proprietary medicinal products which are to remain in that Member State, if appropriate arrangements have been made with the exporting country to ensure that those controls have been carried out in the exporting country. Where these products are imported in the packaging in which they are to be sold by retail, Member States may allow exceptions to the requirements laid down in Article 17. 2. In all cases and particularly where the proprietary medicinal products are released for sale the qualified person must certify in a register or equivalent document provided for that purpose that each production batch satisfies the provisions of this Article ; the said register or equivalent document must be kept up to date as operations are carried out and must remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member State concerned and in any event for at least five years.

← 2. · All articles · 1. →

Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.