FAQ Medical sample

What are the requirements for the labelling of medical devices regarding the release by a qualified person or market release?

According to AMG § 2 (10) and AMBO § 2 No. 10, the labelling of medicinal products is a manufacturing step and thus requires a corresponding approval by the qualified person of a manufacturer. The approval or rejection of the subsequent physician sample labelling according to § 48 Labelling Ordinance 2008 has to be made by the qualified person of the manufacturer or the manufacturer commissioned in writing by the marketing authorisation holder for this step. However, no new market release is required. If the physician sample labelling is carried out by a qualified manufacturer as an activity on behalf according to Section 29 AMBO 2009, approval of this manufacturer in the dossier of the drug in question is not required. All other requirements for physician samples remain unaffected.

What special features must be contained when storing medical samples?

In principle, medical samples are medicinal products and, as such, must be "clearly arranged and stored in such a way that their quality is not impaired and contamination or cross-contamination is avoided" in accordance with Section 30(1) AMBO 2009. Likewise, the requirements for operating rooms are clearly specified in Section 11(1) AMBO 2009: "The operating rooms must be in a proper structural condition and must be suitable for the work to be performed in the company in each case and must be available in sufficient number and size to ensure the manufacture, control or storage of medicinal products in accordance with the respective state of scientific knowledge. Separate operating rooms must be provided for the manufacture, control or storage of medicinal products. These shall be protected by suitable measures against access by unauthorized persons." Storage is also possible under the following conditions at an address other than that specified in the company's own operating license:

- Which products are stored under which storage conditions and for which period of time in which rooms or equipment must be mapped out in a contract.

- Equipment / compartments used shall be listed in the space allocation plan or in the list of equipment used in the establishment (including inventory number).

- Premises and, if applicable, equipment (coolers, active transport boxes, etc.) shall be qualified and maintained in accordance with GMP/GDP requirements.

- Written procedures for pest control shall be established.

- Written procedures for handling product recalls and inventory shall be established.

- Regular audits of all affected warehouses for proper storage and to determine any deviations shall be conducted and records maintained.

- Inspections by BASG can be carried out at such warehouses on a random basis as part of an inspection.

Are medical sample stockpiles reflected in the scope of appropriation?

Yes, they are included under item 1.4.3 "Other" in the scope of authorisation of drug manufacturers, or under item 2.5 "Other activities" in the scope of authorisation of drug wholesalers. A list of overused equipment/compartments is kept as an integral part of the notice. There is no separate authorisation for each location. If an external service provider is commissioned, the service provider has to have a corresponding, valid operating license. The above-mentioned requirements apply mutatis mutandis and are also checked during periodic re-inspections.

Is batch documentation also mandatory for medical samples?

Yes. The corresponding regulation can be found in §§ 15 ff or § 22 of the Austrian Ordinance on Good Manufacturing Practices 2009 (AMBO 2009) BGBl. II No. 324/2008, as amended.


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