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Regulation concerning the examination of variations to the terms of a marketing authorization for medicinal products falling under Council Regulation (EEC) No 2309/93.
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How to fill out REGULATION (EC) No 542/95

01
Read the full text of REGULATION (EC) No 542/95 to understand its requirements.
02
Gather all necessary information related to the products in question.
03
Identify the relevant sections in the regulation that apply to your products.
04
Complete the required forms as specified in the regulation, ensuring all fields are filled accurately.
05
Attach any supporting documents required by the regulation to your submission.
06
Submit the completed forms and documents to the appropriate authority as indicated in the regulation.

Who needs REGULATION (EC) No 542/95?

01
Businesses and entities involved in the marketing, import, or export of certain products covered by the regulation.
02
Regulatory agencies requiring compliance for product safety and standards.
03
Importers and exporters in the EU who deal with products subject to specific controls and standards.
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People Also Ask about

1049/2001 regarding public access to European Parliament, Council and Commission documents, whose purpose is to give the fullest possible effect to the right of public access to documents and to lay down the general principles and limits on such access in ance with Article 255 (2).
The Insolvency Regulation is an EU Regulation concerning the rules of jurisdiction for opening insolvency proceedings in the European Union. It determines which member states' courts have jurisdiction.
An EC Regulation refers to the rules and guidelines set by the European Commission to regulate and oversee various products, including medical devices, within the European Union.
Commission Regulation (EU) 2017/542 of 22 March 2017 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures by adding an Annex on harmonised information relating to emergency health response (Text with EEA relevance. )
Council Regulation (EC) No. 2200/96 on the common organization of the market in fruit and vegetables. This Regulation sets up a common organization of the market in fruit and vegetables. Products to be delivered fresh to the consumer may be classified by reference to a set of standards.
It seeks to regulate the claims* on foods labelled and advertised in the European Union (EU). It aims to ensure that nutrition claims* and health claims* on food labels and in presentations and advertising are clear and based on evidence that is generally accepted by the scientific community.
On 12 July 2023, the Foreign Subsidies Regulation ('FSR') started to apply. This new set of rules enables the Commission to investigate financial contributions granted by non-EU governments to companies operating in the EU.
Regulation (EC) No. 1924/2006 sets out the legal framework for businesses wanting to make nutrition and/or health claims on their products.

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REGULATION (EC) No 542/95 is a European Union regulation that establishes a framework for measures aimed at protecting the environment and promoting sustainable development within the scope of the Union's environmental policy.
Entities engaged in specific activities that may impact the environment, including businesses and organizations operating within the European Union, are required to file REGULATION (EC) No 542/95.
To fill out REGULATION (EC) No 542/95, entities must complete a prescribed form provided by the relevant authority, detailing their activities, environmental impact assessments, and compliance measures undertaken.
The purpose of REGULATION (EC) No 542/95 is to ensure that environmental protection measures are effectively implemented and to enhance transparency and accountability among entities that may affect the environment.
The information that must be reported includes details of the entity's operations, assessments of potential environmental impacts, measures taken to mitigate these impacts, and any relevant monitoring data.
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Relevant keywords

variation marketing authorization medicinal products Regulation (EEC) No 2309/93 safety restrictions minor variations major variations urgent safety restrictions European Agency for the Evaluation of Medicinal Products pharmacovigilance

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