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Explaining Section 10 exemption

17 September 2004Pharmacists are exempt from licensing requirements pertaining to the provision of medicines in certain circumstances, as described

Guidance for the Approval of Suppliers of Raw Materials Used in the Manufacture of Unlicensed Medicinal Products 3rd edition (Yellow Cover)

25 May 2010This document is intended to provide a guidance framework for NHS Specials’ manufacturing activity for a consistent and risk-based approach to evaluate and approve suppliers…

A Standard Protocol for Deriving and Assessment of Stability Part 3 – Oral Liquid Medicines

29 February 2016This document is intended to cover stability testing of all oral liquid formulations including suspensions, emulsions, solutions and powders for reconstitution

Guidance Handling of Monoclonal Antibody (mAb) and Products (Yellow Cover)

16 December 2016Variation in practice underlined the need for an evidence-based guideline for handling mAbs that was suited to all those providing care to NHS patients.

A Standard Protocol for Deriving and Assessment of Stability - Part 1 Aseptic Preparation

23 January 2017This YCD applies to small molecule products of all presentations prepared by aseptic manipulation of sterile pharmaceutical products.

Standard Protocol for Deriving and Assessment of Stability - Part 2: Aseptic Preparations (Biopharmaceuticals)

6 March 2017Stability of the protein structure is an important feature in preserving the safety and efficacy of biopharmaceuticals.

Preparation of medicines in clinical areas by pharmacy staff: the legal and regulatory framework

9 May 2017This document has been prepared to inform the professional judgment which a Chief Pharmacist needs to make if asked to advise their Trust’s senior management…

A Standard Protocol for Derivation and Assessment of Stability Part 4 – Parenteral Nutrition

1 June 2017To support NHS compounding units and purchasers to derive and assess stability data for pharmaceutical products (Specials and extemporaneously compounded).

Standard Protocol for Deriving and Assessment of Stability - Part 5 Sterile Products

1 June 2017This protocol applies to small molecule products of all presentations, manufactured from non-sterile starting materials and sterilised in their final container.

Guidance to the NHS on the licensing provisions of the Medicines Act 1968. (Medicines Control Agency, 1992)

2 April 2019This document provides guidance and advice which is still relevant to the NHS today, on the application of the licensing provisions of the Medicines Act…