Marketing Authorisation Definition

GLOSSARY

/ˈmɑːkɪtɪŋ/ /ɔːθərʌɪˈzeɪʃ(ə)n/

Published by a ��Ӱ�� Life Sciences expert

What does Marketing Authorisation mean?

The approval needed to place a medicinal product on the market. It sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the holder of the marketing authorisation.

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Marketing authorisations: EU decentralised procedure—flowchart

Marketing authorisations: EU decentralised procedure—flowchart No medicinal product may be placed on the market unless it has been approved. This Flowchart outlines the procedure for obtaining an approval known as a marketing authorisation (MA) through the EU decentralised procedure. The decentralised procedure is used to obtain MAs for medicinal products in more than one EU Member State in parallel. A medicine may only be authorised in individual Member States in parallel if it is not mandated to be authorised via the centralised procedure (ie products containing new active substances; products which constitute a significant therapeutic, scientific or technical innovation or products for which the granting of an EU authorisation would be in the interest of patients or animal health at EU level) and medicines that have not received an MA in any Member State already at the time a decentralised application is

EU centralised marketing authorisation procedure—flowchart

EU centralised marketing authorisation procedure—flowchart No medicinal product may be placed on the market unless it has been approved. This Flowchart outlines the procedure for obtaining an approval, known as a marketing authorisation (MA) through the EU centralised procedure. Under the centralised authorisation procedure, pharmaceutical companies submit a single MA application to the European Medicines Agency (EMA) and successful applicants receive a centralised MA which is granted by the European Commission. This Flowchart should be used in

What does IP completion day mean for Life Sciences? [Archived]

What does IP completion day mean for Life Sciences? [Archived] ARCHIVED: This Practice Note has been archived and is no longer maintained. 11 pm (GMT) on 31 December 2020 marked the end of the implementation period put in place to enable the UK to transition away from the EU’s laws and institutions. At this point in time (referred to in this document as ‘IP completion day’) there was an immediate and significant change in the UK’s legal regime. This Practice Note explains the implications of this change in relation to the following life sciences areas: • Overview—what happened on 31 December 2020 • How does Brexit impact the life sciences sector? • EU-UK Trade and Cooperation Agreement—life sciences provisions • Medicinal products • Medical devices • Clinical trials For a tracker of key life sciences Brexit legislation and guidance, see Practice Note: Life sciences—Brexit tracker 2020–2022 [Archived]. For the impact of the end of the implementation period on patents and supplementary protection certificates (SPCs), see Practice Note: What does...

Pharmaceutical trade marks and parallel imports

Pharmaceutical trade marks and parallel imports Pharmaceutical trade marks: regulation and naming procedures In most fields of business, trade mark owners have a relatively free hand in selecting the brands they use to market their goods or services. In general, where there is no risk of confusion on the part of the relevant consumer with an earlier brand, a trade mark will be free for use. This is not the case with respect to trade marks for pharmaceutical products, which are subject to an extra layer of regulation in order to protect public health. Pharmaceutical trade marks can only be put into commercial use once they have been granted a marketing authorisation (MA). In determining whether to grant an MA, the competent authorities will decide whether the trade mark poses a risk to public health. This decision is not reached through a classical trade mark infringement assessment, but instead centres on the potential for medication errors which could lead to serious health risks. The various considerations...

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Medicinal products due diligence questionnaire

Medicinal products due diligence questionnaire Introduction This medicinal products regulatory due diligence questionnaire relates to the proposed purchase by [insert buyer name] (the Buyer) of the [entire share capital of [insert name of target company] Limited incorporated in England and Wales under number [insert company number] (the Company) OR [insert description of the business to be acquired] (the Business) as a going concern, together with certain assets used in the Business] from [insert seller name] (the Seller) (the Proposed Acquisition). This questionnaire is designed to enable the Buyer, the Buyer’s solicitors and other professional advisors to obtain the legal information relating to the medicinal products UK and EU regulatory compliance of the [Company OR Business] which the Buyer requires to assist in the valuation of the [Company OR Business] and with the negotiation of the Proposed Acquisition. Please answer every question fully. Please provide your answers in italics underneath each question and provide copies of all relevant documentation, ensuring...

Clinical Research Organisation (CRO) master services agreement

Clinical Research Organisation (CRO) master services agreement This Agreement is made on [date] Parties 1 [Insert the company name] a company registered in [England and Wales] under company number [insert registered number] and whose registered office at [insert address] (The Sponsor); and 2 [Insert the company name] a company registered in [England and Wales] under company number [insert registered number] whose registered office is at [insert address] (The CRO) (each of the Sponsor and the CRO being a party and together the Sponsor and the CRO are the parties). Background (A) The Sponsor is sponsoring a series of clinical trials in support of marketing authorisation for the IMP and wishes to engage the CRO for certain services. (B) The CRO is knowledgeable and experienced in the design, management and conduct of clinical trials and wishes to provide such services to the Sponsor subject to the terms and conditions set out in this Agreement. The parties agree 1 Definitions and interpretation 1.1 Definitions In this Agreement: Applicable...

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What regulatory responsibilities does an administrator have when acting as the administrator in the insolvency of a pharmaceutical or biotech company that holds marketing authorisations in respect of medicinal products? Does the marketing authorisation transfer to the insolvency practitioner?

What regulatory responsibilities does an administrator have when acting as the administrator in the insolvency of a pharmaceutical or biotech company that holds marketing authorisations in respect of medicinal products? Does the marketing authorisation transfer to the insolvency practitioner? The general duties of an administrator are given in Schedule B1, paragraphs 67 and 68 of the Insolvency Act 1986 (IA 1986). An administrator shall take custody of all the property to which they think they are entitled and shall manage the affairs, business and property of the company in accordance with the proposals prepared by the administrator under IA 1986, Sch B1, para 49 and approved by creditors under IA 1986, Sch B1, para 53. The administrator must also comply with any directions from the court and can apply to court for directions under IA 1986, Sch B1, para 63. IA 1986, Sch B1, para 69 states that the administrator, when carrying out their functions under IA 1986, Sch B1, is an agent of the company. This...

Is supplementary protection certificate protection available for an adjuvant?

Is supplementary protection certificate protection available for an adjuvant? A supplementary protection certificates (SPCs) is an intellectual property right that is distinct from the original patent, but provides similar protection for pharmaceutical products which have obtained regulatory marketing authorisations. The SPC system was set up to compensate pharmaceutical manufacturers for the considerable length of time. It can take between filing a patent application and obtaining the regulatory marketing authorisation required for a pharmaceutical product to be supplied. An SPC operates upon expiry of the patent’s term and lasts for up to five years. The primary legislation governing SPCs consists of Regulation (EC) 469/2009 (Medicinal Products Regulation) and Regulation (EC) 1610/96 (Plant Protection Regulation). The respective regulations have been implemented in the UK through Schedule 4A to the Patents Act 1977. In relation to a medicinal product, the subject matter protected by the SPC is the ‘product’, defined in Article 1(b) of the Medicinal Products Regulation as the ‘active ingredient or combination of active ingredients of a medicinal...

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UPC preliminary measures—emerging trends

EU Law analysis: Preliminary measures, including injunctions and seizure of goods, covering all of the Unified Patent Court (UPC) participating Member States are a powerful tool for patentees. As a counterbalance, potential infringers are permitted to file protective letters, which, while not eliminating the risk of a preliminary injunction, have the potential to prevent a preliminary injunction being issued ex parte. Stephanie Wroe, associate and Patent Attorney at D Young & Co, explores some of the trends emerging from the case law.

EMA issues guidelines on drug shortage mitigation and prevention plans

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released comprehensive guidelines to assist pharmaceutical companies in implementing Shortage Mitigation Plans (SMPs) and Shortage Prevention Plans (SPPs). These measures aim to address the escalating issue of medicine shortages across Europe, exacerbated by the COVID-19 pandemic, which has significantly impacted patient care and treatment availability.

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