Operating
licences

There are a range of authority licences and registrations that you may need to be able to legally operate in the UK and to supply or sell abroad.

Do I need this?

If you legally purchase, own, store and/or supply medicinal product in the UK you will most likely need at least one authority licence to operate legally.

HTF have advised many clients and successfully assisted them with obtaining the right type of licence(s) required for a wide range of products and supply chain models.

Related services.

There are a range of licences/registrations that you might need, depending on the product type and the supply chain/ownership model you are operating with.

Wholesale Distribution Authorisation (Human) WDA (H)

Whether it is for a UK or an Irish WDA(H) we have helped many clients to successfully obtain a WDA(H) licence, managing the whole process from application through inspection to award of licence.

Manufacturer/Importer Authorisation MIA

We are experienced in helping clients obtain a UK MIA that is specifically required for importing UK licensed medicines into the UK from outside the UK/EU.

Manufacturer/Importer Authorisation for Investigational Medicinal Products MIA (IMP)

A UK MIA (IMP) is required for importing medicines into the UK from outside the UK/EU. Our team of experts can help with the whole process.

Manufacturer’s Specials Licence MS

When importing unlicensed medicines into the UK from outside the UK/EU, a UK MS licence is required. Our experts can guide you through this process.

Broker Registration BRKR

We are experienced in helping clients register as a Broker, when a person or company facilitates a transaction involving medicinal products between a supplier and a customer but does not take part directly in the transaction (and never owns or handles the product).

Active Pharmaceutical Ingredients Registration API

We are experienced in helping clients register for handling API;  a regulatory requirement when a company owns API and either stores, moves or sells it to the next stage in the manufacturing supply chain.

Controlled Drugs (CD) Licence

Any medicinal product containing a controlled drug product (defined by the UK Home Office) will require a UK Home Office CD licence in addition to a WDA(H). Our experts assist with obtaining the relevant schedule of licence for the product.

Human Tissue Authority (HTA) Licence

An HTA Licence is often needed as part of an Advanced Therapy Medicinal Product (ATMP) supply chain. This begins with a tissue sample from a patient, which is transported to the manufacturing site. Our experts can manage the project from application through to licence and provide a Designated Individual (DI) named on the licence.

Decoration

Get in
touch

If you need more detailed information on any of these related services, or advice on which services you do need, please get in touch.

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How we can help.

Whether you need some support for your existing quality team or need HTF to manage the whole of a new licence project, we can provide the expertise and collaborative approach that will result in an on-time and successful project.

Often our project team then continue as key contract resources in the operational aspects that follow.

A process that starts at any point.

No two clients or products are the same and everything we do for a client is bespoke, making use of the wide variety of our team’s previous experiences.

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From an initial meeting, we can often understand in broad terms what is needed and what part we can provide. There is no cost or obligation to use HTF at this stage.

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We help obtain or update a licence

We can manage the project from application through the inspection(s) to award of the licence(s).

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You have your own team at HTF

Each client has one or more regular HTF personnel working with them, creating a close working relationship. In addition, the knowledge base of the whole team is always available to every client.

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Adapt and evolve our service

As a client’s resources, product portfolio and general situation change, we can adapt our services to suit, providing increased or decreased services as required by you.

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Longstanding relationship built

We often partner with our clients for many years, flexing our services as their situation changes.

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We make any amendments

Licences are regularly varied and expanded, we can manage these as smaller projects.

Case study.

We never divulge confidential details of any client publicly, but here is an anonymised example of a typical project we have handled recently.

UK client with an existing WDA

They wanted to launch a new product requiring a Controlled Drug (CD) Licence

HTF assisted the client in assessing and then expanding their QMS to accommodate CD products, extending the agreement with their pre-wholesaler, applying to the UK Home Office for a CD licence, implementing and training the changes with the client. The client is now considering whether to have HTF provide an additional RP/RPi for their WDA to act as back-up and support for the existing employee in this role.

What did we do?

Offered advice

Expanded their QMS

Extended pre-wholesaler agreement

CD licence obtained

Let’s talk.

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expert right now!

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+44 (0) 1527 572060

enquiry@htfassociates.co.uk

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