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This regulation establishes the registration of the name 'Kraški pršut' as a protected geographical indication (PGI) under EU law, following the necessary procedures outlined in Regulation (EC)
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How to fill out COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012
01
Obtain the form for COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012 from the official EU website.
02
Read the accompanying instructions carefully to understand the requirements.
03
Fill in the identification section with your details, including name, address, and relevant contact information.
04
Provide necessary information about the product or service related to the regulation.
05
Include any required documentation or evidence as specified in the regulation.
06
Double-check all information for accuracy and completeness.
07
Sign and date the form where required.
08
Submit the completed form through the designated submission channel.
Who needs COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012?
01
Businesses involved in the marketing or distribution of pharmaceuticals within the EU.
02
Regulatory authorities responsible for the oversight of medical products.
03
Healthcare professionals seeking compliance with EU regulations.
04
Legal entities involved in clinical trials or research within the EU.
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Implementing regulations take precedent over national legislation in case the two contradict one another. Implementing regulations are always limited in scope. Their aim is to ensure uniform implementation of European legislation, and the subject-matter of any implementing regulations serves that goal alone.
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What is COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012?
COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012 establishes a uniform procedure for the assessment of the authorization of medicinal products for human use and for the supervision of post-marketing phase for medicinal products, ensuring public health safety.
Who is required to file COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012?
Pharmaceutical companies and organizations involved in the development and marketing of medicinal products for human use must file under COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012.
How to fill out COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012?
Filing under COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012 requires submitting specific forms which include information on the product, risk management plans, and safety data in accordance with the guidelines provided in the regulation.
What is the purpose of COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012?
The purpose of COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012 is to ensure that new medical products are safely authorized and effectively monitored post-marketing, with a focus on maintaining high standards for public health.
What information must be reported on COMMISSION IMPLEMENTING REGULATION (EU) No 506/2012?
Information required includes product specifications, data on clinical trials, risk assessment and mitigation strategies, as well as any adverse reactions associated with the medicinal product.
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