Part 2: Human Medicines Chapter 1: Regulations Section 3: Manufacture, marketing and supply
Section 3(1) lists matters relating to the manufacture, marketing and supply of human medicines that regulations made under section 2(1) can address. The list is exhaustive.
	Subsection (1)(a) allows provision to be made in relation to manufacturing authorisations. As a general rule, a manufacturing authorisation is required by any person manufacturing human medicine in the UK as set out in regulation 17 (manufacturing of medicinal products) of the Human Medicines Regulations 2012 (HMRs). Regulations made under section 2(1) and relying on section 3(1)(a) could, for example, amend the application process for applying for such an authorisation, add to the requirements that must be met by the holder of a manufacturing authorisation or amend the exceptions to the requirement for a manufacturing authorisation.
	Subsection (1)(b) allows provision to be made in relation to authorisations to import human medicines. In general, regulatory rules are in place to secure supply chains for medicines entering the UK. A manufacturer’s licence is required in order to import medicines into the UK from outside the EEA, as set out in regulation 17 of the HMRs. A wholesale dealer’s licence is required in order to import unlicensed medicines from within the EEA, as set out in regulation 167(7) of the HMRs. Regulations made under section 2(1) and relying on section 3(1)(b) could, for example, amend the requirements relating to importation that must be met by the holders of such authorisations.
	Subsection (1)(c) allows provision to be made in relation to wholesale dealing authorisations. Generally, a wholesale dealing authorisation is required by any person supplying medicines by way of wholesale dealing in the UK. This is governed by regulation 18 (wholesale dealing in medicinal products) of the HMRs. Wholesale dealers are the middle-persons in the supply chain moving products from manufacturers to the persons who will actually supply the product to its end user. Usually wholesale dealers are distribution companies but not necessarily – if a hospital supplies a medicine to another hospital then that is also an example of wholesale dealing and will need an authorisation unless an exception applies. Regulations made under section 2(1) and relying on section 3(1)(c) provision could, for example, amend the application process for applying for such an authorisation, add to the requirements that must be met by the holder of a wholesale dealing authorisation or amend the exceptions to the requirement for a wholesale dealing authorisation.
	Subsection (1)(d) allows provision to be made in relation to marketing authorisations. As a general rule, a marketing authorisation is required by any person who wishes to place a medicine on the UK market. This is governed by Part 4 (requirement for authorisation) of the HMRs. Regulations made under this provision could, for example, amend the application process for applying for such an authorisation, add to the requirements that must be met by the holder of the authorisation or amend the exceptions to the requirement for a marketing authorisation.
	Subsection (1)(e) allows provision to be made in relation to the importation, distribution and manufacture of active pharmaceutical substances. These are the raw ingredients used to make finished medicines and give a medicine its therapeutic effect. Chapter 4 of Part 3 of the HMRs requires any person who imports, manufactures, or distributes an active substance to register with the MHRA. The MHRA has produced a flowchart  that provides further information on the stages of the registration process.
	Subsection (1)(f) allows provision to be made in relation to the brokering of medicines. Brokering of medicinal products consists of negotiating independently and on behalf of another legal or natural person in relation to the sale or purchase of medicinal products. Under Chapter 3 of Part 3 of the HMRs, brokers have to register with the MHRA. As part of this they must have a permanent address in the UK and comply with the guidelines on good distribution practice (GDP), insofar as those guidelines apply to brokers.
	Subsection (1)(g) provides that regulatory provisions may be made in relation to the registration of the premises of a pharmacy business. "Pharmacy business" is defined at section 9.
	Subsection (1)(h) allows provision to be made in relation to the recording of information about the supply of human medicines. Regulation 253 of the HMRs currently require, with some exceptions, a pharmacy to keep records in respect of the sale or supply of prescription only medicines (POMs). Regulations made under section 2(1) and relying on section 3(1)(h) provision could, for example, amend these requirements.
	Subsection (1)(i) allows provision to be made in relation to notifying and reporting requirements. This would include requirements relating to the reporting of adverse reactions to medicines which are used to ensure that emerging risks in connection with a medicine are identified and acted upon as early as possible.
	Subsection (1)(j) allows provision to be made in relation to the labelling and packaging of human medicines as well as the patient information leaflets (PILs) that accompany them. Existing requirements are found in Part 13 (packaging and leaflets) of the HMRs. Regulations made under section 2(1) and relying on this provision could update the existing requirements to allow further for the provision of information online and/or through other emerging media platforms or they could be used to create new requirements to address gaps identified in the provision of information, for example to require that patient information leaflets are included in both boxes where a pharmacist splits a product between two patients.
Example (1): Labelling and Leafletting
The labelling and leafletting of medicines in the UK are currently regulated by Part 13 (Packaging and Leaflets) of the HMRs. MHRA approves all packaging and labelling information for medicines sold in the UK including the information that must be provided. Medicines must include a patient information leaflet (PIL) if the label does not contain all the necessary information. It is essential for certain medicines that they are dispensed together with a PIL and other risk minimisation materials. An example of how this power may be used could be to make provision imposing an obligation on the holders of marketing authorisations for medicinal products, to make available the information which must be included in the package leaflet associated with such product, at all times in electronic format.
	Subsection (1)(k) allows provision to be made in relation to the advertising of human medicines. Existing requirements are found at Part 14 (advertising) of the HMRs. Regulations made under section 2(1) and relying on the provision could, for example, allow some of the information that must appear in adverts to healthcare professionals to be provided via a web link rather than included in the advert’s small print.
	Subsection (1)(l) provides that regulations made under section 2(1) may make provision relating to the registration of persons who sell human medicines over the internet. Currently Part 12A (sale of medicines to the public at a distance) of the HMRs requires persons who sell medicinal products to the public over the internet to notify the licensing authority and comply with certain requirements. This power could, for example, be used to introduce a national scheme to replace the EU scheme.
	Subsection (1)(m) provides that regulatory provision may be made in relation to the requirements that need to be met for a prescription to be valid. Current requirements are found in regulations 217 to 219A in Part 12 (Dealing with Medicinal Products) of the HMRs. Regulations made relying on subsection (1)(m) could, for example, amend the particulars that must be included in a prescription or the types of prescriptions that can be sent electronically.
	Subsection (1)(n) provides that amendments may be made to provisions in the general rules on who can supply human medicines and from where they can be supplied. The rules are set out in subsection (2) and include regulations 214 (sale or supply of prescription only medicines), 215 (prescribing and administration by supplementary prescribers), 220 (sale or supply of medicinal products not subject for general sale), 221 (sale or supply of medicinal products subject for general sale) and 249 (restrictions on persons to be supplied with medical products) of the HMRs. These provide that prescription only medicines (POMs) can only be supplied in accordance with a prescription and set out who can issue prescriptions. They also set out that medicinal products that are not subject to general sale (POMs and pharmacy medicines) must be supplied from a registered pharmacy, while general sale medicines need to be supplied from premises that can be closed off to exclude the public. Finally, they restrict who can be supplied with medicinal products by way of wholesale dealing. There are multiple exemptions from these rules set out in Chapter 3, Part 12 of the HMRs and the associated Schedules. An example of an existing exemption is one that enables Royal National Lifeboat Institution (RNLI) first aiders to supply prescription only medicines in the course of their work for the RNLI when needed to treat the injured. Another exemption allows schools to obtain asthma inhalers and to supply them in an emergency to pupils who are known to suffer from asthma. Regulations made under section 2(1) and relying on section 3(1)(n) could, for example, be used to allow additional healthcare professionals to be given appropriately restricted prescribing rights or to amend the exemptions to the requirement for a prescription.
Example (2): Prescribing Policy
Some medicines are available to patients where they are given a prescription by an appropriate practitioner. An appropriate practitioner can either be an independent prescriber (someone able to prescribe medicines under their own initiative), or a supplementary prescriber (someone able to prescribe medicines in accordance with a pre-agreed care plan that has been drawn up between a doctor and their patient).
Part 12, Chapter 2 of the HMRs sets out which groups of healthcare professionals are regarded as having the appropriate qualifications to make prescribing decisions and such groups are granted the responsibility to prescribe, either generally or in a defined set of circumstances. Over time the roles of staff within the health service will evolve and using this proposed power, certain professionals will be added to this list by amending the HMRs.
	Subsection (1)(o) provides that regulations can be made about the use of human tissues or cells in relation to human medicines. Human tissues or cells are defined by regulation 5(1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (SI 2007/1523).