Examples of 'marketing authorisation holders' in a sentence
Meaning of "marketing authorisation holders"
This phrase is mainly used in the pharmaceutical and medical industries. It refers to individuals or organizations who have been granted official authorization or permission to market or distribute a specific product, such as a medication. It typically denotes the legal entity responsible for obtaining and maintaining the necessary approvals and compliance for the marketing of such products
How to use "marketing authorisation holders" in a sentence
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marketing authorisation holders
Reporting especially for marketing authorisation holders.
The cost to marketing authorisation holders of the additional information provision.
In order to further ensure that marketing authorisation holders.
All marketing authorisation holders should implement risk minimisation measures.
Should ensure that marketing authorisation holders.
Two residue depletion studies were submitted by two of the concerned marketing authorisation holders.
Certificates from marketing authorisation holders.
Marketing authorisation holders may be a valuable source of non promotional information on their medicinal products.
Responsibilities of the marketing authorisation holders.
Marketing authorisation holders shall submit an application for a variation of the marketing authorisation accordingly.
It is appropriate to allow marketing authorisation holders to.
Marketing authorisation holders have in any case to abide by Community law.
Performing pharmacovigilance inspections at the marketing authorisation holders.
The duties of the marketing authorisation holders should also be reinforced.
A large number of marketing authorisations and marketing authorisation holders.
See also
marketing authorisation
marketing authorisation holder
marketing authorisation number
marketing authorisation valid
marketing authorisation holder
marketing authorisation number
marketing authorisation valid
Marketing authorisation holders are required to submit a PSUR at regular intervals or upon request.
Residues depletion data were submitted by two of the affected marketing authorisation holders.
No new data was submitted by the marketing authorisation holders during the appeal procedure.
Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders.
The grounds for appeal lodged by marketing authorisation holders can be summarised as follows.
Marketing authorisation holders shall access those reports through the Eudravigilance database.
The announcement shall include information on how marketing authorisation holders and the public can participate.
Marketing authorisation holders may submit questions regarding issues relating to Nordic packages.
Derivation of withdrawal periods for milk Marketing authorisation holders approach.
Marketing authorisation holders shall submit to the Agency periodic safety update reports containing.
Member States shall ensure that marketing authorisation holders register internet websites.
The requirement to be established in the Union shall also apply to marketing authorisation holders.
The marketing authorisation holders provided a Phase II environmental risk assessment.
The Commission shall publish the names of the marketing authorisation holders involved.
Marketing Authorisation Holders have started uploading data to the repository.
Applicants for marketing authorisations and marketing authorisation holders shall be established in the Union.
Competent authorities and the Agency shall supervise the pharmacovigilance systems of marketing authorisation holders.
Member States should therefore not impose on marketing authorisation holders any additional reporting requirements.
The CVMP has assessed three dose determination studies provided by the Marketing Authorisation Holders.
The CVMP and marketing authorisation holders proceeded New centralised applications.
Electronic submission will facilitate data exchange between applicants and marketing authorisation holders with the EMEA.
The data submitted by the Marketing Authorisation Holders was only for chickens and turkeys.
Collection of data by Member States and responsibilities of marketing authorisation holders.
The marketing authorisation holders were requested to provide the following,.
Notwithstanding the intention of the Marketing Authorisation Holders to withdraw all Marketing.
The marketing authorisation holders should implement risk minimisation measures ;.
The CHMP reviewed all the information made available by the Marketing Authorisation Holders.
However, marketing authorisation holders remain legally responsible for those tasks.
The CVMP has assessed five dose determination studies provided by the Marketing Authorisation Holders.
Enable marketing authorisation holders to provide objective and non-promotional information in an understandable way.
Standard operating procedure on the release of assessment reports to applicants / marketing authorisation holders.
In addition the marketing authorisation holders of chlormadinone should perform a post-authorisation safety study.
Registered in the EU, shall be followed by marketing authorisation holders.
Marketing authorisation holders who are in doubt about the necessity of package leaflets can contact:.
Reports of suspected adverse reactions - from marketing authorisation holders of medicinal products for human use.
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