Anzeige der sachkundigen Person nach §14 Arzneimittelgesetz Bestätigung
Hamburg
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99005023008000
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Typ 2a
Inhalt
<div lang="en-x-mtfrom-de">Notification of the competent person according to §14 Drugs Act Confirmation</div>
<div lang="en-x-mtfrom-de">Notify a competent person according to the Medicines Act</div>
Begriffe im Kontext
<div lang="en-x-mtfrom-de">Pharmaceuticals</div> (Synonym), <div lang="en-x-mtfrom-de">Medicines Act</div> (Synonym), <div lang="en-x-mtfrom-de">advertisement</div> (Synonym), <div lang="en-x-mtfrom-de">AMG</div> (Synonym), <div lang="en-x-mtfrom-de">Qualified Person</div> (Synonym), <div lang="en-x-mtfrom-de">pharmaceutical manufacturer</div> (Synonym), <div lang="en-x-mtfrom-de">drug manufacturer</div> (Synonym)
Fachlich freigegeben am
06.05.2022
Fachlich freigegeben durch
nicht vorhanden
If you operate a pharmaceutical company that markets finished medicinal products, you must notify the competent authority of a qualified person. You must also notify them immediately of any changes to the qualified person.
The Medicines Act sets out the requirements for various responsible persons. To obtain permission to manufacture medicines, you must report a competent person with the appropriate qualifications and reliability to the competent authority.
- Job references (copy)
- Training certificate (copy)
- CV
- Certificate of good conduct (copy)
- Declaration of designation form
- commitment declaration
- Competent persons must have the necessary expertise and reliability.
- You need a university degree in pharmacy, chemistry, biology, human or veterinary medicine,
- Alternatively, completed training in the aforementioned areas or proof of employment as a pharmaceutical representative
- You can notify a competent person in writing or electronically.
- Submit the competent person’s report with all required documents to the competent authority.
- The authority will examine your report and the documents submitted. If necessary, it will request further documents or information from you.
- Once all the necessary documents and information have been provided, the responsible authority will decide on your report.
- You will be informed of the decision.
- The ad can be confirmed or rejected.
- You will receive a fee statement with a request for payment.
The processing time depends on the administrative effort and is approximately 1 to 4 weeks.
You need the certification of your qualified person from the competent authority in order to obtain permission to manufacture medicinal products and to manufacture medicinal products.
Report any changes affecting the Qualified Person immediately.
Report any changes affecting the Qualified Person immediately.
If you manufacture medicinal products without a qualified person confirmed by the competent authority, or if you do not immediately report changes that affect the qualified person, you are violating the Medicines Act. This can lead to a fine.
- contradiction
- Information on how you object will be transmitted with the decision on your ad.
- Notification of the competent person according to Section 14 of the Medicines Act
- The Medicines Act describes the requirements for various responsible persons.
- In order for a pharmaceutical company to obtain a manufacturing license, a competent person with appropriate qualifications and reliability must be reported to the responsible supervisory authority.
- To notify us of responsibility, please use the online service or submit the document in writing.