FAQ Certificates
I need a GM/DP certificate. What to do?
A GM/DP certificate is reserved for companies with a valid operating license under pharmaceutical law in accordance with Section 63 of the Austrian Medicines Act (AMG). The basis for issuing a GM/DP certificate is the existence of a positive inspection result. In accordance with § 67 AMG, this may not be more than two, three or five years in the past. A GM/DP certificate is issued both by the authorities (§ 68 Para. 5 AMG) and on application by authorized applicants.
The application for GM/DP certificates is made via the eService Inspektionen & Überwachung.
In addition, the existence of a GM/DP certificate can be queried and viewed online via the Union database.
In the event that a GM/DP certificate cannot be issued (negative inspection result), an NCR (Non Compliance Report) is issued officially and published in the Union database and on the BASG homepage.
An inspection according to § 67 AMG has taken place in my company. Can GMDP certificates be applied for until the current procedure is completed?
The GMDP certificate is issued at the earliest possible time. If a company inspection according to § 67 AMG does not reveal any critical/serious deficiencies and/or requests for comments, the GMDP certificate is usually issued together with the inspection assessment before party hearing (§ 63 AMG/§ 65 AMG) or the initial inspection report (§ 67 AMG). Until then, no GMDP certificates are issued.
My company is a manufacturer of medicinal products and places other medicinal products on the market. Is the marketing of all medicinal products covered by the GMP certificate?
According to the current format, the GMP certificate or the manufacturing authorization covers only the placing on the market of the medicinal products manufactured in the company. If additional medicinal products are placed on the market, a GDP certificate is also issued and an operating license for placing medicinal products on the market is issued in the course of licensing procedures pursuant to Section 63 AMG or Section 65 AMG.
My company is a manufacturer of active ingredients that have not yet been included in a marketing authorization and does not want these to be publicly displayed in our GMP certificate. What is the procedure here?
In the course of the inspection, the company must provide an assignment of the abbreviations used to the names (German and English according to the designation in applications for clinical trials, approvals) of the active substances. If explicitly requested, these abbreviations will be indicated in the GMP certificate issued. In EudraGMDP, the names are entered as "confidential" so that they are only accessible to authorities. Once the drugs have been approved, no abbreviations are used in GMP certificates.
