We frequently take part in discovery calls with entrepreneurs and commercial teams with ideas or opportunities to bring a medicinal product to the UK and other markets.

Often this can be from spotting a gap in the market or a pricing opportunity and is achieved through buying the rights to license a dossier or transferring the ownership of an existing product licence.

While the business potential from this is attractive, many underestimate the complexity of what’s required. Although most examples are achievable – often with limited need for in-house resources, as explained later – success depends not only on obtaining licensing and marketing rights of the product but also on meeting the strict regulatory, quality, and pharmacovigilance obligations.

To avoid repetition and to assist those thinking of achieving this, we’ve put together this high-level overview of the key steps and requirements.

Step 1 – Company Set-Up

Using the UK as an example, to become a product licence holder, with a view to marketing your product, you must have established a legal entity either in the UK or the European Economic Area (EEA). This company will hold the licence for your product and be legally responsible for various aspects, including ensuring ongoing compliance.

Setting up your company is a relatively simple process that can be achieved rapidly. You will need to decide on the company format (e.g. limited liability partnership, private limited company or a sole trader in the UK) and its structure, plus you will require a registered office.

IMPORTANT: Although regulatory can help here, it’s best you seek legal advice as this is quite an important decision.

Step 2 – Accessing or Creating your Dossier

To gain your product licence you’ll need to submit a marketing authorisation application (MAA) or partake in a change of ownership application (COA). Either way, your product will require a full dossier – in the format of an electronic Common Technical Document (eCTD) – to support the chosen application. Options to achieve this include:

• Purchasing rights to an existing dossier.
• In-licensing a product from a current product license holder.
• Developing a new product through your own non-clinical and clinical programme.

The chosen route affects your costs, time, and regulatory strategy. For most start-ups the development of a new product is unlikely, mainly due to the restrictive costs and time involved in designing and running non-clinical and clinical studies.

IMPORTANT: To fully understand your available options and to develop a robust strategy it is important to engage early with regulatory experts.

Step 3 – Regulatory Pathways

Different submission options exist regardless of where you intend to market your product. These can vary from country to country. Using the UK as an example, an application to the Medicines and Healthcare products Regulatory Agency (MHRA) can follow various types of legal basis, such as a full application, generic, hybrid, biosimilar, well-established use and more. These can then follow differing routes of registration such as:

• National assessment procedure, the statutory time for these is 210 days – excluding ‘clock stops’ to respond to questions – and applies for each legal basis. A faster route of 150 days is available for innovative medicines, e.g. new active substances, biologicals, new combinations of active substances, orphan medicinal products and conditional or exceptional circumstances authorisations.
• International Recognition Procedure (IRP), relatively new, this post-Brexit opportunity allows the recognition of non-UK approvals from selected ‘Reference Regulators’, including the EU/EMA, US, Canada, Switzerland and more. Depending on the age of the approval being relied on, plus other factors, dictates the time taken to receiving authorisation – the shortest being 60 days for Route A and 110 days for Route B (both excluding any clock-stops).

NOTE: Other paths and opportunities do exist for less standard applications but are not discussed here.

IMPORTANT: Understanding which path applies to your product is critical to avoid wasted effort or rejected applications. Reaching the right decision can involve meeting with the regulatory authority to discuss your options upfront, and an experienced regulatory affairs teams can guide you through this.

Step 4 – Due Diligence and Gap Analysis

We’re assuming that you’re not developing a new product. As such, you’ll be presented with a dossier, or at least parts of a dossier. How do you know if it’s fit for purpose?

This is where regulatory due diligence comes in. It’s where qualified regulatory experts will review the available data against the current regulatory requirements and your planned regulatory pathway.

IMPORTANT: Your due diligence and gap analysis findings are instrumental in fine-tuning your deal with the existing product licence holder and/or manufacturer and finalising your regulatory and wider business strategies.

Step 5 – Manufacturing and Supply Chain

Your product must be manufactured and released to the market by appropriately authorised and inspected facilities and qualified persons:

• Manufacturer, these must hold the appropriate license(s) and GXP certification (e.g. GMP, GDP, GLP etc.).
• Qualified Person (QP), they are legally required to certify each batch before it can be released onto the market.
• Supply chain partners, these must comply with Good Distribution Practice (GDP) and any other nationally applicable requirements.

IMPORTANT: Your partners must be carefully selected and audited; however, they’re not required to be a part of your organisation.

Step 6 – Essential Functions and Expertise

As touched on above, start-ups and other smaller organisations will require access to various key roles, and these can be either in-house or, as we commonly encounter, via outsourcing. These include:

• Regulatory Affairs, to strategically advise, prepare and submit applications and manage the lifecycle post approval (e.g. variations and renewals).
• Quality Assurance, responsible for ensuring GMP and GDP compliance
• Qualified Person (QP), inputs into the Quality Assurance function and release product batches into the market.
• Pharmacovigilance / QPPV, to maintain safety oversight for each product and a Qualified Person Responsible for Pharmacovigilance (QPPV).
• Medical Affairs, to provide suitably qualified medical and clinical advice, usually via a medical director and a supporting medical information team.
• Commercial expertise, essential for contract negotiation, launch planning, pricing, and distribution.

IMPORTANT: Without these functions in place it’s difficult, if not impossible to obtain or maintain a product licence, with some being legally required.

Step 7 – Lifecycle Management

Once your product is authorised, the work continues. For example, you must:

• Keep the dossier up to date through variations submitted to the regulator.
• Maintain pharmacovigilance systems and report safety issues.
• Ensure batch testing and release are performed correctly.
• Pass MHRA inspections if required.

IMPORTANT: Failure in any of the above areas can risks suspension or withdrawal of your licence.

What does this all cost?

The million dollar question – no pun intended!

We can speak only from a regulatory point of view on the activities we describe above. These include client meetings, contract manufacturer meetings, agency meetings, due diligence (including gap analysis), strategy input, dossier build, labelling and artwork generation, leaflet user testing, eCTD publishing, submission, responses to agency questions, and lifecycle support. These alone will run into the 10s of thousands (GBP) and are essential to achieve a successful product licence authorisation and market launch.

The other costs, including buying the rights to license a product, manufacturing and distribution costs, quality, safety and medical functions, and licence maintenance fees must also be factored in. These are not strictly in our area of expertise but we do possess some knowledge and experience.

All of the above should not be thought of as prohibitory – just look at the number of new product licences authorised each month – however they must be carefully considered.

In Summary…

Hopefully by now you can deduce that bringing a medicinal product to the market is quite involved. Spotting the commercial opportunity and acquiring a dossier can be the simplest part. Taking it through to market requires the right company structure, access to expertise, compliant partners, and a clear regulatory strategy.

For start-ups, outsourcing these specialised functions is often the most efficient and cost-effective way to move forward – ensuring your product is brought to market in a compliant and commercially viable way.

We hope you find this information of use. If you’re considering entering the UK or any other market with a medicinal product, we are more than willing to have a no obligation FREE discovery call with you to discuss your plans and help you understand the best route forward.

* These products are provided by third parties and are only shown as illustrative examples. If you would like to learn more please contact us and we can provide further details.