Marketing Authorisation Holders

Information on (usage within expiry date, storage, signs of deterioration, qualitative composition, pharmaceutical form and content, name and address of marketing authorisation holder and manufacturer)... 

Special storage conditions Special precautions about disposal, if applicable Name and address of the marketing authorisation holder Marketing authorisation number Batch number... 

In the EU, a basic requirement for marketing authorisation holders (MAHs) is that they must have permanently and continuously at their disposal a nominated qualified person, with responsibility for pharmacovigilance. This person should have experience in all aspects of pharmacovigilance and, if not the holder of a medical or veterinary qualification, they should have access to such a person. The duties of the qualified person include ... 

Marketing authorisation holders are obliged to submit Periodic Safety Update Reports (PSURs) according to the frequencies outlined as follows ... 

E should be investigated by the regulatory body and, if necessary, the drug should be withdrawn prior to informing the marketing authorisation holder... 

Any personnel of the marketing authorisation holder - including sales representatives. 

In the case of relevant worldwide scientific literature, the clock starts with awareness of the publication by any personnel of the marketing authorisation holder the marketing authorisation holder is expected to maintain awareness of possible publications by accessing a widely used systematic literature review and reference database, such as Medline, Excerpta Medica or Embase, no less frequently than once a week, or by making formal contractual arrangements with a second party to perform this task marketing authorisation holders are also expected to ensure that relevant publications in each Member State are appropriately reviewed. 

They need assurance that the medicines they are offered fulfil these requirements and are supported by information that permits optimal use. The information about and the usage of medicines gets out of date, and there is an obligation on licence holders continually to review their licence with particular regard to safety. Marketing Authorisation Holders (MAH), i.e. pharmaceutical companies, can also change the efficacy claims to their licence, e.g. new indications, extension of age groups, or... 

Marketing authorisation holder / name, address, country, tel., fax/... 

Marketing authorisation holder 14. Marketing authorisation holder... 

The marketing authorisation holder of these other substances or preparations, his or her tradename and/or brand names of these other substances or medicinal products are not bought into discredit. 

The comparison does not give rise to any confusion between the substances or medicinal products being compared with each other and their brand names and/or between the marketing authorisation holders involved and/or their tradenames. 

Marketing authorisation holders must refrain from the following activities involving practitioners ... 

Marketing authorisation holders must refrain from offering or providing practitioners with discounts in the form of gifts (including bonus deliveries of other medicinal products or products alien to the sector). This provision does not apply to discounts made in connection with the supply of medicinal products provided that, in the case of discounts either in kind, in the form of bonus deliveries of the same drug, or in cash, these are made expressly in writing (specifically on an invoice or credit note). 

Holders of marketing authorisations must ensure that reward of practitioners is in reasonable proportion to the work done, irrespective of whether this is in cash or kind for advice or services rendered. Also the advisory work or the services rendered must not give rise to any connection between the marketing authorisation holders and the practitioners, other than the direct relationship with the advisory work or services rendered. 

Marketing authorisation holders must maintain adequate records of the samples of medicinal products provided by them and of the prescribing practitioners to whom they have furnished the samples, as well as the quantities involved. These records must be retained for 5 years. 

Marketing authorisation holders must ensure that, when offering hospitality to practitioners, this hospitality remains within reasonable bounds and is subordinate to the objective of the gathering. 

The indication that comprehensive information can be found in the professional information for the medicinal product and, if necessary, listing the medium in which the marketing authorisation holder makes it available to professionals who are entitled to prescribe, dispense or administer the medicinal products in humans, in accordance with the respective specifications of the legislation on therapeutic products. 

Notice to marketing authorisation holders - pharma-covigilance guidelines no. PhVWP/108/99. 

Every Member State has local legislation and obligations for maintaining effective pharmacovigilance and there are criminal, civil and/or regulatory penalties for non-compliance by marketing authorisation holders. 

The first of these guidelines lays down the roles and responsibilities of the marketing authorisation holders and of the national competent authorities in respect of the products authorised through the national procedures (including mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. 

Marketing authorisation holder s role and responsibilities include having a named, qualified person responsible for pharmacovigilance at the EU level, and there may be a need for an additional named person at the national level when this is required. The duties of the qualified person include ... 

The full revised text of the Notice to Applicants Volume 2B has been available since June 2001. The revised provisions, which take into account the ICH agreements, are ultimately intended to replace the previous structure of the European marketing authorisation dossier described in the 1998 edition of Volume 2B. However, in order to take into account the fact that the marketing authorisation holders may need some time to adapt their current procedures, it has been agreed that both the previous 1998 edition of Volume 2B and the new edition published in June 2001 will coexist for some time. Therefore, from 1 July 2001 the legal requirements governing the particulars and documents to accompany an application for marketing authorisation may be fulfilled by reference to either the 2001 edition or to the previous 1998 edition of Volume 2B (EudraLex Vol 2B). 

Referrals 10,000 for arbitration/referrals triggered under Articles 10(2), 11, 12 and 15 of Council Directive 75/319/EEC or Article 7.5 of Commission Regulation (EC) No. 541/95, as amended. 50,000 for referrals under Article 11 and 12 of Council Directive 75/319/EEC, or Article 5.3 of Commission Regulation (EC) No. 541/95, as amended, initiated at the instigation of the applicant/marketing authorisation holder... 

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