Medicines
Prestige Compliance Regulatory Consultants in Nottingham use Knowledge, Expertise, and Experience, which enables us to offer Comprehensive Compliance Solutions that incorporate all your requirements. We provide Professional Regulatory Affairs Consultancy Services for Manufacturers, Suppliers, and Distributors.
What are classed as Medicines?
Regulations, Directives and Guidelines for Medicines ensure that Medicines and Vaccinations work properly and meet the Standards of Safety, Quality, and Efficacy. Legal Frameworks for Pharmaceuticals are aimed at ensuring a high level of protection of Public Health. The placing of a medicine on the Market should be subject to the granting of a Marketing Authorisation by the Competent Authorities. Directives, Regulations and Guidelines ensure the Authorisation, supply, and monitoring of Veterinary Medicinal Products are also in place. These comprehensive controls ensure that safe, effective, and quality veterinary medicines are available for the health and welfare of animals, whilst safeguarding people and the environment.
Law in the European Union and Great Britain
In the European Union, use for veterinary and human medicines are governed by Directive 2001/82/EC and Directive 2001/83/EC respectively. The centralized Authorisation procedure for human and veterinary medicines is based on Regulation (EC) No 726/2004 of the European Parliament and of the Council laying down Community procedures for the Authorisation and supervision of Medicinal Products for Human and Veterinary use. The Human Medicines Regulations 2012 and The Veterinary Medicines Regulations 2013 are the main Legislation in the Great Britain covering the manufacture, importation, distribution, advertising, labelling, sale, and supply of medical products for Human and Veterinary use.
Law in the USA and Canada
In the United States of America, the Food and Drug Administration (FDA) is responsible for enforcing Regulations for protecting public health by assuring the Safety, Efficacy, and Security of Human and Veterinary Drugs as well as Biological Products through the Federal Food, Drug and Cosmetic Act (FD&C Act). Requirements for the Manufacture, Packaging, Labelling, Storage, Importation, Distribution and Sale of Prescription and Non-prescription drugs in Canada are set out in the Food and Drug Regulations. Requirements for Drug Clinical Trials are also set out in the Regulations.
What We Can Do
Prestige Compliance Regulatory Consultants in Nottingham provide Regulatory Support and Advice to assist with meeting all Regulatory Requirements, helping you navigate on the International Regulatory Landscape.
Regulations, Directives, and Guidelines for Human and Veterinary Medicines are often very complex. Our Experts provide a thorough Regulatory Strategy which is fundamental to getting Products on the Market. We help you identify Regulations for specific Geographical Regions to ensure Compliance to Regulations in all your Market Regions as well as expansion to New Markets.
Prestige Compliance support your Business needs from Product Innovation through to Market Authorisation.
Our Experts are here to help you achieve Regulatory Compliance
Contact our Regulatory Consultants in Nottingham to arrange an initial consultation.