What does Marketing Authorisation mean? Marketing authorisation is, in practice, the medicines regulator’s permission to place a medicinal product on the market. It specifies the authorised indications (medical conditions), patient population and dosage, and sets any conditions binding on the marketing authorisation holder (MAH). It is the legal basis for supply and promotion and underpins the Summary of Product Characteristics (SmPC), patient information leaflet and labelling. Use outside it is “off-label”. It is a statutory concept: in the UK under the Human Medicines Regulations 2012, and in Ireland under Directive 2001/83/EC and Regulation (EC) No 726/2004. In Great Britain, the MHRA grants national marketing...
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This Practice Note is designed to monitor the progress of EU cases relevant to the life sciences industry. For earlier life sciences materials, see Practice Note: Life sciences tracker [Archived]...
For archived supplementary protection certificate (SPC) judgments, see Practice Note: Life sciences tracker [Archived]-Judgments-Supplementary protection certificates...
Requirements for obtaining an SPC for medicinal products-combination product-meanings of ‘product protected by a basic patent in force’ (Article 3(a)) and ‘product that has not already been the subject of an SPC’ (Article 3(c)). This ruling examines the criteria under Article 3(a) and 3(c) of Regulation (EC) 469/2009...
When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...
This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...
I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...