When it comes to regulatory affairs documents, not least in the context of highly regulated sectors, such as pharmaceuticals and healthcare, it is essential to have the right documentation in place when exporting certain shipments of goods.

At Blair, we provide a comprehensive list of documentation, certification, and authentication services for both the pharmaceutical and healthcare sectors, including global legalisation services, as well as regulatory submissions and filing within the UK and overseas markets.

What are regulatory affairs documents?

Regulatory affairs, also known as governmental affairs, refer to the process of regulating and monitoring the development, manufacture, testing, licensing, labelling, registration, and marketing of products from a range of different industries, including the pharmaceutical and healthcare industry.

As such, regulatory affairs documents refer to the documentation needed in relation to a whole range of products — from medicines to cosmetics — to be able to show that those products are regulatory compliant and fit for the open market.

Why is regulatory documentation needed?

Regulatory affairs is essentially designed to protect public health by controlling the safety and efficacy of products in key areas. These include pharmaceuticals, medical devices, veterinary medicines, pesticides, agrochemicals, cosmetics, and complementary medicines.

In turn, regulatory affairs documentation helps to ensure that the companies responsible for the discovery, the required tests, the manufacturing process, the necessary quality control, and the domestic or international marketing of these products are acting in accordance with strict rules and standards when it comes to public health, safety, and welfare.

By having stringent safety standards in place to minimise any significant risk of harm, and by requiring documentary evidence that these standards have been met — from proof of risk assessment and standard operating procedures to good clinical practice with data from clinical trials — the relevant regulatory authority can be satisfied that reasonable steps have been taken to keep the public safe. In this way, regulatory approval can be obtained.

Where is this documentation sourced from?

Our services for regulatory documentation were initiated in the early 1990s as a result of the increasing level of demand from our existing client base. In addition to providing a comprehensive Embassy Legalisation service, we also provide both in-house and external support for our clients’ submission of documents to each relevant regulatory authority in the UK, as well as regulatory authorities overseas, including any necessary follow-up applications to maintain regulatory approval.

These include submissions to the following:

The Department of Health and Social Care (DHSC)

The DHSC is a government department responsible for government policy on health and adult social care matters in England, along with certain elements of the same matters which are not otherwise devolved to the Scottish Government, Welsh Government, or Northern Ireland.

The Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA is an executive agency of the DHSC in the UK, responsible for ensuring that medicines and medical devices work and are acceptably safe for use.

The Department for Environment, Food & Rural Affairs (Defra)

The Defra is a UK government department for Environment, Food and Rural Affairs responsible for environmental protection, food production and standards, agriculture, fisheries, and rural communities, not just in England but across the whole UK.

The Veterinary Medicines Directorate (VMD)

The VMD is a Defra-sponsored executive agency to protect animal health, public health, and the environment.

The Department for Business and Trade (DBT)

The DBT is a government department with overall responsibility for the statutory and regulatory framework of export controls, and for decisions to grant or refuse an export license.

The European Medicines Agency (EMA)

The EMA is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines within the EU.

Why is assistance with regulatory documentation required?

The statutory and applicable regulatory requirements of export controls when shipping pharmaceutical, medicinal, and other highly regulated products overseas, including certification and licensing, can be highly complex.
However, the process of obtaining the proper regulatory affairs documents can be easily streamlined and expedited using Blair’s expert documentation service providers.

How can Blair help with regulatory documentation?

Typical regulatory affairs applications undertaken by Blair on a daily basis include those to the DHSC, MHRA, Defra, VMD, DBT, and EMA, including a document identification and document management service. We also prepare and process thousands of pharmaceutical-related and other regulatory documents for Embassy Legalisation on a weekly basis for a range of clients, including manufacturers, exporters, and third-party agencies.

Depending on the foreign market concerned, we will evaluate the optimum legalisation route in terms of regulatory compliance, speed, and expense to deliver the most cost- and time-effective service to our customers, to be assessed on a case-by-case basis.

Additionally, where required as part of the legalisation process for shipments of goods in the context of certain overseas markets, we can provide expert technical translations for all pharmaceutical and other regulatory affairs documents — including clinical documents and other technical documents — using experienced certified translators.

To discuss your regulatory requirements in the context of exporting pharmaceutical and other regulated goods overseas, including making regulatory submissions and seeking regulatory approval on your behalf, please contact our sales team on +44 (0) 1784 254123 or use our online contact form to learn more today.

Legal disclaimer

The matters contained within this article are intended to be for general information purposes only. This blog does not constitute legal advice, nor is it a complete or authoritative statement of the law in England and Wales and should not be treated as such. Whilst every effort is made to ensure that the information is correct, no warranty, either express or implied, is given as to the accuracy of the blog contents, and no liability is accepted for any errors or omissions. Before acting on any of the information contained herein, expert advice should be sought.