Manufacture, marketing and sale

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Manufacture, marketing and sale guidance:

This Practice Note introduces and considers the general principles that apply to the advertising and promotion of medicinal products as well as the accompanying rules on...

Practice Note

EU and UK legal framework governing medicinal products A complex array of requirements and guidelines developed at both EU and EU Member State levels govern the following...

Practice Note

This Practice Note summarises the main types of legal action that can be taken against the UK trade in counterfeit goods, the pros and cons of each and includes some...

Practice Note

What is a biosimilar? A similar biological medicinal product (commonly termed 'biosimilar') is a medicinal product that is similar to a biological medicinal product (the...

Practice Note

This Practice Note deals with key issues that are likely to affect the life sciences sector as a result of the UK’s withdrawal from the EU. It outlines the possible...

Practice Note

This Practice Note deals with the key issues that are likely to affect the medical devices sector as a result of the UK’s withdrawal from the EU. For considerations on...

Practice Note

This Practice Note deals with the key issues that are likely to affect the regulation of medicinal products as a result of the UK’s withdrawal from the EU. It briefly...

Practice Note

Introduction to the medicines advertising enforcement landscape Directive 2001/83/EC on the Community code relating to medicinal products for human use...

Practice Note

A worldwide problem, for developed and developing countries alike, is the trade of falsified medicinal products. The terms ‘falsified medicines’ and...

Practice Note

What is a borderline product? It is often obvious whether a product should be classified as a medicinal product, medical device, cosmetic product, food, or...

Practice Note

As explained in the Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products, no medicinal product may be placed on the market...

Practice Note

No medicinal product may be placed on the market without having first obtained an approval known as a marketing authorisation (MA). The MA sets out the medical conditions...

Practice Note

Orphan medicinal products (OMPs) are medicines used to prevent, diagnose or treat rare medical conditions and diseases. Given that the number of patients...

Practice Note

Scope This Practice Note explains trade mark law on parallel trade. Parallel imports, or ‘grey market’ goods, are genuine goods that are placed on the market by, or with...

Practice Note

European level rules on pricing and reimbursement of medicinal products The pricing and reimbursement of medicinal products and medical devices is not harmonised across...

Practice Note

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...

Practice Note

What is product liability? Products sold to consumers must be safe. In the UK, product safety is governed by a wide legal and regulatory framework, with certain high-risk...

Practice Note

What are e-cigarettes? Electronic cigarettes (commonly known as ‘e-cigarettes’, ‘vapourisers’ or ‘vapes’) are products that can be used to consume nicotine-containing...

Practice Note

Directive 2001/83/EC (consolidated version 28.01.2019), the Pharmaceutical Code establishes a period of ‘data exclusivity’ from the initial authorisation of...

Practice Note

Online shopping offers unprecedented choice for consumers and easy access to a global market place. However, while the majority of e-commerce sales are legitimate, the...

Practice Note

A key proposition underpinning EU competition law is that competing companies should act independently on markets. In principle, rivalry and competition can be expected...

Practice Note

The development of medicine, biomicrobiology and biotechnology has led to the emergence of a relatively new category of medicinal products that use gene therapy, somatic...

Practice Note

An introduction to unlicensed medicinal products and off-label use of medicinal products In the EU, Article 6 of Directive 2001/83/EC (consolidated version 28.01.2019),...

Practice Note

This Practice Note examines the meaning of advertising within the regulatory framework on the advertising and promotion of medicinal products. It considers what...

Practice Note