The European Medicines Agency and Future Marketing Authorisation Procedures PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download The European Medicines Agency and Future Marketing Authorisation Procedures PDF full book. Access full book title The European Medicines Agency and Future Marketing Authorisation Procedures by Great Britain. Parliament. House of Lords. Select Committee on the European Communities. Download full books in PDF and EPUB format.
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 123
Get Book Here
Book Description
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 123
Get Book Here
Book Description
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN:
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: Great Britain. Parliament. House of Lords. Select Committee on the European Communities
Publisher:
ISBN: 9780104012925
Category : Drugs
Languages : en
Pages : 100
Get Book Here
Book Description
Author: Ewout Johan Marius van Ginneken
Publisher: Univerlagtuberlin
ISBN: 379832235X
Category :
Languages : en
Pages : 210
Get Book Here
Book Description
Author: Sally Shorthose
Publisher: Kluwer Law International B.V.
ISBN: 9403530235
Category : Law
Languages : en
Pages : 840
Get Book Here
Book Description
In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Author: United States. General Accounting Office
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 30
Get Book Here
Book Description
Author: Manish Mudaliar
Publisher: LAP Lambert Academic Publishing
ISBN: 9783659515668
Category :
Languages : en
Pages : 80
Get Book Here
Book Description
Biological medicinal products cover a diverse field. In the European Union, many of these are under the responsibility of the European Medicines Agency and are authorised via the centralised marketing authorisation procedure, such as products manufactured by biotechnology, or advanced therapy medicinal products. Naturally derived biological maybe nationally authorised in individual Member States, rather than through the pan European procedure. Due to the diverse nature of biological products, a number of specialised groups have been established within the Agency to supervise and coordinate activities related to these products. The regulation of follow-on biologics is a rising concern for the biotech industry since many biologics are approaching the end of their patent life, and as a result, will open the market for more affordable generics."
Author: José Luis Valverde
Publisher: IOS Press
ISBN: 9781586035211
Category : Business & Economics
Languages : en
Pages : 154
Get Book Here
Book Description
In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge.
Author: Sally Shorthose
Publisher: Kluwer Law International B.V.
ISBN: 9041170022
Category : Law
Languages : en
Pages : 590
Get Book Here
Book Description
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Author: Commission of the European Communities
Publisher:
ISBN: 9789282820605
Category : Drugs
Languages : en
Pages : 196
Get Book Here
Book Description
Recoge: 1.Marketing authorisations - 2.Mutual recognition - 3.Community referral - 4.Centralised procedure - 5.Variations - 6.Community marketing authorisation - 7.General information.
