Initial permits as well as modification permits are issued immediately, provided that neither critical nor serious defects were identified during the inspection. If critical or serious deficiencies are found, their irreversible elimination must be initiated in a documented manner (plan of action in the course of the hearing of the parties) before a license can be issued. The authorization is issued by the Federal Office for Safety in Health Care on the respective announced federal office dates (lead time for this: ~ 10 days).
If the application is withdrawn or rejected after the examination of the formal requirements of the application has been completed, the entire fee must be paid in accordance with § 1 (3) of the Ordinance of the Federal Office for Safety in Health Care on the Fee Tariff pursuant to the GESG. In this case, the procedure has already reached the end of the substantive examination.
A relocation is a substantial change within the meaning of Section 65 of the Medicines Act (AMG):
"Section 65. (1) Substantial changes with regard to the manufacture, marketing or control of medicinal products, in particular with regard to the information pursuant to Section 63(2)(1) to (3), which may have an impact on the nature of the medicinal products or the production or distribution program, require a permit from the Federal Office for Safety in Health Care within the meaning of Section 63(1)[...]."
Changes of address are subject to approval, therefore an application for a change of the operating license under pharmaceutical law according to § 65 AMG has to be submitted to the Federal Office for Safety in Health Care. The submission is made via the eService Inspections & Monitoring.
Changes of address that relate to the relocation of an office in the same building are subject to approval if address details, such as staircase and door number, are also listed in the corresponding notice/authorization.
Address changes resulting from official renaming (e.g. change of street name) do not require approval. An adjustment to this effect in the GMP and/or GDP certificate is made immediately. The adjustment in the permit will be made within the framework of the next change in accordance with the official notice and will remain valid until then.
Specifically addressed are the requirements of § 63 (2) 1-3 AMG: 1. type, scope and location of the intended activity, 2. nature, size, equipment, dedication and location of the premises and their equipment, 3. nature of the technical equipment, [...].
Accordingly, the following shall be considered as a substantial change:
- ad 1. the complete relocation of a licensed establishment, additional production processes or even the production of additional dosage forms. This category also includes the processing / production of additional active ingredients (especially toxic or sensitizing active ingredients).
- ad 2 Any new construction or addition to, or rededication of, rooms in which quality-relevant activities are to be carried out (e.g. production rooms, warehouses, laboratories) must be applied for in advance to the BASG. Alterations to rooms must be applied for in advance to the BASG if they result in changes in the flow of materials, personnel or influence existing cleanroom classes. Changes of address of office establishments (placing of medicinal products on the market, restricted to office operation / manufacture of medicinal products, restricted to office operation) must be applied for with the BASG immediately upon moving into the new business premises or taking over the new business location in the company register.
- ad 3 In the case of additional equipment or the exchange of existing equipment, consideration must be given to whether both the functional principle and capacities remain unchanged. In the event of a change in the functional principle or an increase in capacity of more than 100% compared to the actual status or in the event of changes in sterile processes, an application for a change in accordance with § 65 AMG must be submitted to the BASG in each case.
In all cases, the respective change must be mapped in the company's internal quality system.
The "place of actual import" is harmonized under European law. The relevant entry in the GMP certificate represents part of the manufacture of the medicinal product in question. The entry means that the site in question must be GMP-certified for the receipt and storage of imported products that are still awaiting QP certification for release on the medicinal product market in the EEA. The following options are available to an importer who takes the place of a manufacturer in the EEA in the case of an import from a third country: 1) The importer obtains the necessary authorization for the site concerned himself. If the site at which the QP certification is performed by the importer and the site at which the "place of actual import" is performed differ, the importer must obtain separate operating permits for both sites. 2) The importer commissions a service provider who has the required operating license for the manufacture of medicinal products. In this case, a corresponding agreement must be in place between the competent persons involved, taking into account the requirements of Annex 16 to the Guide to Good Manufacturing Practice. If the test samples are not taken at the "place of actual import", it must be demonstrated that the test samples sent to the manufacturer for analysis are representative of the batches supplied. Documents proving compliance with points 1.5.3 to 1.5.7 of Annex 16 to the Guide to Good Manufacturing Practice must be kept available at the premises involved and presented to BASG on request.
Austrian drug authorizations (WDA [Wholesale Dealer Authorization] or MIA [Manufacturing / Importers Authorization]) are usually issued without an expiration date. The date shown in EudraGMDP (authorization date) corresponds to the initial authorization date, even if subsequent changes are made. The actuality of the respective marketing authorization can be checked via the accompanying GM/DP certificates.