Medicines licensing

Why do we need a license?

• illegal to manufacture, assemble, import or distribute without a licence, certificate or exemption

• Provider standards oof quality and safety

• Regulation and licensing introduced through Medicines Act. Updated within HMR 2012

licensing agency

MHRA

What does the MHRA stand for?

Medicines and Healthcare products regulatory Agency

MA

Marketing Authorisation

What is an MA

• name given to the license with full regulatory approval in UK

• Places restrictions on the products

• Defies legal classification of the medicine

What does the MA allow?

Sale, supply, import and export of a medicinal product

Procurement for sale, supply etc

CTA

Clinical trial authorisation

Use of CTA

Permits for purposes of trial

• sale or supply of medicinal product

• Manufacture or assemble for sale or supply

• Import into the UK

EAMS

Early access to medicines scheme

What are EAMS for ?

• given to those with life threatening or debilitating conditions with no alternative

• Permits ordering, manufacturing and distribution if MHRA are satisfied

• Require pharmacovigilance

• Advertising is prohibited

IRP

International recognition procedure

Abridged applications are for …

For generic medicines

How long is MA legally valid for?

Up to a period of 5 years

→> after renewal valid indefinitley

MIA

Manufacturing and importing Authorisation

How to obtain an MIA?

• demonstrate GMP

• Have a QP in charge

• Licenser has an MA of making it to specification to MA

General labelling requiresments

• indelible , legible and comprehensible

• In English

• Standard labelling particulars

• From 2025 —> ‘UK only’

Package leaflets requirements

• legible, clear and easy to use

• Written in accordance with SmPC

Standard labelling particulars for medicinal products

• Nam of product in braille on outer packaging

• Legal classification

• May include symbols diagrams or pictograms to clarify

• modified rules for : blister, small containers and containing paracetamol

Parallel importing

• modified license for product imported from an approved country (mostly EEA)

• Version of a product with a full UK MA

• In English

WDA

Wholesale Distribution Authorisation

Wholesale dealing

• sale or supply to someone else

• Administer or be administered to someone else

GDP

Good distribution practice

Responsible person

• knowledge and experience of activities undertaken

Exemptions for MIA or WDA license

• practitioners- to particular patient

• Pharmacists- against prescription

• Named patient supply- in accordance with prescription

• Specials - for individual patient

Herbal remedy Licensing

• from dried/ crushed/powdered plant

• pure herb possibly just water

• Only totes actual contents no recommendation for use

Herbal medicinal product licensing

• herbal substance

• Herbal preparation to produce liquid form

• No other active ingredient

• Includes recommendation

herbal medicinal product must be either:

• licensed medication (have MA if masks medicinal claim)

• Traditional herbal medicinal product —> THR number, PIL, minor conditions, evidence of safety & quality

What is an SSP

serious shortage protocols

protocol allowing pharmacists to supply an alternative medicine during serious shortages