{"id":2217,"date":"2017-07-25T14:42:22","date_gmt":"2017-07-25T14:42:22","guid":{"rendered":"https:\/\/mediregs.south.co.uk\/?p=2217"},"modified":"2017-10-02T14:44:27","modified_gmt":"2017-10-02T14:44:27","slug":"wholesale-distributors-require-pharmacovigilance-agreements","status":"publish","type":"post","link":"https:\/\/mediregs.eu\/wholesale-distributors-require-pharmacovigilance-agreements\/","title":{"rendered":"Do wholesale distributors require pharmacovigilance agreements?"},"content":{"rendered":"

Re-printed from the original at MHRA Inspectorate Blog.<\/p>\n

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Do wholesale distributors require pharmacovigilance agreements?<\/h1>\n<\/header>\n
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MHRA Good Distribution Practice (GDP) inspectors have received queries from wholesaler distributors asking in what instances agreements are required between the marketing authorisation holder (MAH) and wholesale distributors for the purposes of fulfilling pharmacovigilance requirements. The Good Pharmacovigilance Practice (GPvP) Inspectorate provides some clarification below.<\/p>\n

According to Article 1(17) of Directive 2001\/83\/EC, wholesale distribution of medicinal products is \u201call activities consisting of procuring, holding, supplying or exporting medicinal products apart from supplying medicinal products to the public\u2026\u201d. If a wholesale distributor could potentially receive safety-related information on behalf of the MAH, or if they are providing a service relating to pharmacovigilance, then they are effectively part of the MAH\u2019s pharmacovigilance system. In this situation, contracts or agreements between the MAH and wholesale distributor need to exist, in order for the MAH to ensure that activities performed and services provided by these third parties are in accordance with applicable legislation and guidelines, and in order to ensure that all parties understand and formally agree to the tasks that have been contracted. In this blog post, the terms contract and agreement are used synonymously.<\/p>\n

Provisions in published guidelines to consider<\/h3>\n

The good pharmacovigilance practices (GVP), are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union.<\/p>\n

GVP Module VI.2.2 states that \u201cEach marketing authorisation holder shall have in place a system for the collection and recording of all reports of suspected adverse reactions which are brought to its attention\u201d<\/em>. As indicated earlier, wholesale distributors may be a potential source of safety information. Hence, the MAH will need to have a mechanism to collect reports of adverse reactions received by wholesaler distributors.<\/p>\n

GVP Module VI.B.7 outlines the reason why agreements between the MAH and wholesale distributors may be required \u201cWhere the marketing authorisation holder has set up contractual arrangements with a person or an organisation, explicit procedures and detailed agreements should exist between the marketing authorisation holder and the person\/organisation to ensure that the marketing authorisation holder can comply with the reporting obligations. These procedures should in particular specify the processes for exchange of safety information, including timelines and regulatory reporting responsibilities and should avoid duplicate reporting to the competent authorities\u201d<\/em>.<\/p>\n

As reports of suspected adverse reactions may be brought to the attention of wholesale distributors, agreements between the MAH and the wholesale distributor support the fulfilment of the collection and recording of these reports by the MAH.<\/p>\n

Indeed, section 6.3 of the European Commission Guidelines on Good Distribution Practice of medicinal products for human use (2013\/C 343\/01) states \u201cIn the event of a complaint about the quality of a medicinal product and a potential product defect, the manufacturer and\/or marketing authorisation holder should be informed without delay\u201d<\/em>. Complaints received by wholesale distributors may include reports of suspected adverse drug reactions and should be forwarded to the MAH, the implementation of an agreement between the parties may help facilitate this activity.<\/p>\n

Factors influencing whether an agreement is required<\/h3>\n

The MAH needs to assess if the wholesale distributor they have engaged with are a potential source of safety information (such as reports of adverse reactions, medical enquiries or product quality complaints), and\/or are providing pharmacovigilance services on behalf of the MAH, and whether an agreement is required to fulfil pharmacovigilance requirements. Some factors which are likely to result in an agreement being required include:<\/p>\n