What is export? and why is export so important in the pharmaceutical industry?

Export is defined as to allow GB goods to leave the customs territory. It is the responsibility of the exported Consignor to ensure that.

• Medicinal products remain in the legal supply chain.
• Export paperwork is completed correctly.
• Proof of export is obtained and retained.
• The consignee is entitled to receive the medicinal product.
• The product has been stored, handled and shipped in accordance with GDP.

The UK pharmaceutical sector is a major contributor to the economy, with exports valued at over £26.1 billion in 2023. The industry benefits from a strong science base, skilled workforce, and a culture of protecting intellectual property. Key markets for UK medicinal products include the European Union, the United States, and emerging markets in Asia and Africa

The United Kingdom has long been a significant player in the global pharmaceutical industry, renowned for its robust research and development capabilities, stringent regulatory standards, and a thriving ecosystem of innovation. Exporting medicinal products from the UK involves navigating a complex landscape of regulations, certifications, and market dynamics.

Exporting medicinal products from the UK requires adherence to a stringent regulatory framework designed to ensure the safety, efficacy, and quality of medicines. The Medicines and Healthcare products Regulatory Agency (MHRA) is the primary body responsible for regulating medicines and medical devices in the UK. Key requirements include:

1. Licensing: Exporters must hold the appropriate licenses, such as a manufacturer’s license, wholesale dealer’s license, and marketing authorization.
2. Controlled Drugs: For controlled substances, exporters need a Home Office controlled drug license in addition to any domestic licenses.
3. Export Certificates: Depending on the destination country, exporters may need to obtain various export certificates, such as the Certificate of a Pharmaceutical Product (CPP).

A licenced wholesale dealer has to ensure that they supply the authorised medicine only to persons in the third country who are authorised or entitled to receive medicinal products for wholesale distribution or supply to the public in accordance with applicable legal and administrative provisions of the third country concerned.

To clear a medicinal product for export HMRC will need to know exactly what is being shipped. Medicinal products presented for export must be accompanied by a Commercial Invoice fully detailing the commodity code to be exported.

A Commodity Code is a type of classification code designated to any goods or products moving in or out of the UK. This numerical ten-digit number is attributed to a wide variety of goods, and every product's type/classification, materials, style, colour and more will be accounted for in this code. A commodity code will dictate things like the duty rating of a product and any restrictions on imports and exports from other countries. As well as this, a commodity code will convey important information such as:

• Whether or not you can apply for a preferential duty rating
• If your product needs an import license
• All the duty and VAT ratings you'll be charged for your products

These commodity codes are used internationally; agreed upon on an international level for a consistent approach to overseas trading. This approach makes the process of trading goods internationally much easier to follow and understand for everyone.

Pro forma invoices must be avoided as these can lead to misleading customs declarations being completed.

Trading with customers in third countries may involve making additional checks with regulatory authority for medicines in the country concerned in order to verify and validate licences etc. The MHRAs expectation is that an authorised Wholesale dealer should have oversight of the exported medicinal product and all the appropriate documentation to evidence it.

The exporter (consignor) is also responsible for ensuring that.

• Medicinal products remain in the legal supply chain.
• Export paperwork is completed correctly.
• Proof of export is obtained and retained.
• The product has been stored, handled and shipped on accordance with GDP guidelines.

A declaration must be made to the HMRC to indicate, what medicinal product is being shipped and where the product is ultimately going.

Shipping Agent

Documentation provided by the shipping agent or freight forwarder must be checked for accuracy to ensure all exportation declaration documentation has been completed correctly. Copies of all exportation documentation must be retained by the exporter.

The freight agent can be invaluable when it comes to territory knowledge for the importation to third countries and any restrictions / embargoes that may be associated with each territory.

Exporting pharmaceutical products the key challenges:

Regulatory Compliance: Different countries have varying regulatory requirements for pharmaceuticals. Ensuring compliance with these regulations, including obtaining necessary licenses and certifications, can be complex and time-consuming.

Quality Assurance: Maintaining the quality and integrity of pharmaceutical products during transportation is crucial. This involves adhering to EU guidelines on Good Distribution Practices (GDP), as well as ensuring proper storage and handling conditions. Ensuring compliance with international standards and maintaining high-quality assurance processes are critical for successful exportation.

Market Access: Gaining access to international markets can be challenging due to trade barriers, tariffs, and non-tariff barriers such as stringent regulatory standards and lengthy approval processes.

Intellectual Property Protection: Protecting intellectual property rights in foreign markets is essential to prevent counterfeiting and unauthorized use of proprietary formulations and technologies.

Logistics and Supply Chain Management: Efficiently managing the logistics and supply chain to ensure timely delivery of products while minimizing costs and risks is a significant challenge. This includes dealing with customs procedures, transportation logistics, and potential disruptions.

Understand each countries climate and the impact on the medicinal product being exported. Suitable temperature-controlled transport solutions to keep medicinal product in their manufactured labelled temperature conditions throughout the entire journey. Understanding of each country temperature-controlled facilities at each final destination airport / port / warehouse

Brexit Impact: For UK exporters, Brexit has introduced additional complexities, including changes in regulatory alignment with the EU, potential delays at borders, and the need to navigate new trade agreements.

Economic and Political Stability: Exporters must consider the economic and political stability of target markets, as instability can affect market access, demand, and the overall business environment.

Cultural and Market Differences: Understanding and adapting to cultural differences and market preferences is crucial for successful market entry and customer acceptance.

Addressing these challenges requires careful planning, robust quality management systems to qualify customers in third countries, and a deep understanding of the target markets.

Challenges and Solutions

Regulatory Variability: Different countries have unique regulatory requirements, which can be challenging to navigate. Solution: Employing regulatory experts and using compliance management software can help manage these complexities.

Supply Chain Disruptions: Events like natural disasters or pandemics can disrupt supply chains. Solution: Building a resilient supply chain with multiple suppliers and robust risk management strategies can mitigate these risks.

Quality Assurance: Maintaining product quality throughout the supply chain is critical. Solution: Implementing stringent quality control measures and using technology for real-time monitoring can ensure product integrity.

Effective supply chain management in pharmaceutical exports is essential for ensuring that patients worldwide receive safe and effective medications. By adopting best practices and leveraging technology, pharmaceutical companies can navigate the complexities of global supply chains and enhance their operational efficiency.