The Gateway to New Pharmaceutical Markets…
Central Pharma enables you to extend your business and brand reach into the UK and EU marketplaces.
Tuesday 11thMay 2021 . Published by Central Pharma
Central Pharma’s comprehensive portfolio of MHRA licenses, for the importation and distribution of pharmaceutical products to markets, along with their expertise in pharmaceutical manufacturing and services, enables them to control the supply chain. This gives 3rd country API manufacturers partnering with Central Pharma the opportunity to access UK and EU marketplaces.
- Experience and Professionalism
- Stimulating business growth
- A gateway to the UK and the EU
- Every step expertly managed
- From bulk goods to packaged product
- Wholesale and Distribution UK
- Wholesale and Distribution EU
Experience and professionalism
Central Pharma’s licenses and adherence to professional standards means that they offer best-in-class, flexible, pharmaceutical supply chain services and manufacturing using Wholesale Dealers Authorisation (WDA), Manufacturers Importation Authorisation (MIA) and official good manufacturing and Distribution practices (GMDPs) guidelines.
As a WDA holder Central Pharma is, in accordance with EU Directive 2001/83/EC, licensed for:
- Pharmaceutical quality management in accordance with the EU GDP Guidelines
- Maintaining premises and facilities for proper storage and distribution
- Providing a person to be responsible for wholesale distribution (Responsible Person)
Their MIA status means that they comply with MHRA regulations, including the recently published Annex 21, covering:
- Physical transfer from a 3rd country to the EU
- Physical receipt of the product
- Certification by a Qualified Person (QP)—interlinking with the requirements of Annex 16 to the EU GMP Guideline
- Pharmaceutical quality system—including deviation, complaint and recall system
- Requirements for buildings and facilities—reference to chapters 3 and 5 of the EU-GMP Guidelines
- Requirements for documentation to be submitted to the QP for certification— provision of documents in a language that can be understood by all parties involved
- GMP requirements for 3rd country manufacturers and exporters—qualification and audits under the responsibility of the importing facility
- Inspection at import, if not from a 3rd country with MRA or ACAA—reference to the detailed regulations in Annex 16
- Contractual regulations between manufacturer in 3rd country, all companies involved in import (for example, analytical laboratory testing facilities) and MIA holder
GMP is woven into the core of Central Pharma’s operations, ensuring that high quality and batch-to-batch consistency are maintained. The following is a summary of typical activities required by GMP guidelines:
- Outsourcing and technical agreements
- Audits and qualification activities
- Communication with manufacturing sites (for example, information on marketing authorisation dossiers, deviations, commitments to the regulatory authority, etc.)
- Product quality assessments
- Quality defects, complaints and product recalls
- Maintaining the supply of medicines
- Continuous improvement activities
Stimulating business growth
Central Pharma enables you to extend your business and brand reach into the UK and EU marketplaces. Having access to the UK and EU will enable more than half a billion potential new customers, to avail 3rd country pharmaceutical products and their brands to affording the opportunity for significant business growth in the two new areas.
So how exactly does Central Pharma provide access to UK and EU marketplaces for 3rd country APIs?
A gateway to the UK and the EU
Central Pharma is UK-based with facilities in the Republic of Ireland. This enables them to offer pharmaceutical companies around the world, and in particular 3rd country API and bulk product manufacturers, a stable gateway into the UK and EU marketplaces using a fiscal import approach.
They offer the same Qualified Person controls, remote batch certification, bulk shipping, filling and packing, Responsible Person documentation review and release, warehousing and distribution services as they did before Brexit. These services remain unaffected by Brexit because Central Pharma’s Republic of Ireland operation is within EU borders.
Adhering to the Republic of Ireland’s Health Products Regulatory Authority (HPRA) requirements enables them to import pharmaceutical and therapeutical products into the Republic of Ireland for access to the local Irish as well as broader EU marketplace.
Every step expertly managed
Starting at your manufacturing site, the products to be imported are assessed and authorised by a Central Pharma Qualified Person (QP). At that point, the bulk product is cleared, on Central Pharma’s behalf, as part of a previously audited supply,. When each batch of bulk product has been released, it’s free to be shipped to the UK for wholesale and distribution or Central Pharma’s Republic of Ireland facility for wholesale and distribution to the EU.
When Central Pharma receives the bulk shipment, their MIA licence enables them to carry out importation testing to clear the product for UK and EU release—testing takes place at their partner laboratories in the UK and Ireland.
When testing is complete, Central Pharma begins primary filling the bulk product and packing and batch certification of the finished product under QP control, with documentation review before authorising the release of finished product to the marketplace.
The final step is the warehousing, storage, handling and distribution of the finished product in an appropriate, safe and secure environment under Central Pharma’s detailed processes and procedures under the authority of their Wholesaler Dealers Authorisation licence (WDA).
Every step of the way Central Pharma offers their experience and expert advice to make product journeys safe, smooth and secure.
All medicines entering the EU must meet regulations set by the European Medicines Agency (EMA). Carrying out regular inspections to verify standards, to assure zero contamination and to establish authenticity outside the country of.
Central Pharma can take control of products from your API or bulk manufacturing site before goods are shipped. To ensure that products will not be impeded by the need to carry out inspection at port, to avoid time consuming delays and to ensure quality, licensing and customs requirements, they purchase your products for fiscal import, giving them title of goods needed for use of Central Pharma’s MIA and WDA
This licensed procurement and onward selling enables you to sell your products in the UK and EU marketplaces via the Central Pharma gateway.
From bulk goods to packaged product
Central Pharma processes your products, filling and packing in a variety of flexible primary, secondary and tertiary solutions using manual and fully automated systems with sophisticated environmental controls for blistering, bottle, tub and sachet filling.
They provide high quality package printing for product branding and marketing information, enabling your products to be easily handled and displayed by retailers.
Wholesale and distribution UK
Being a UK-based company, Central Pharma has facilities for receiving, warehousing, wholesaling and distributing your products across the UK. As such, they comply with Good Distribution Practice (GDP) guidelines, which is prerequisite for their WDA licence. MHRA GDP certificate confirms Central Pharma’s operations pass regular GDP inspections for compliance.
Wholesale and distribution EU
When your products have been packaged and have passed quality control and assurance procedures Central Pharma’s Qualified Person services (QP) ensure that certified finished products are made available to the marketplace.
Within the EU, all commercially licensed products manufactured or imported must have a QP to approve and certify each batch. Central Pharma’s QPs have deep knowledge and understanding of the quality control systems used at their facilities, audited against EU GMP.
The QPs are assigned projects according to their specialist expertise and have personal and legal responsibilities as defined by EU legislation with evidence of:
- Batch certificate confirming QP certification in accordance with Article 51 of Directive 2001/83/EC
- The control report in accordance with Appendix II to EU Goods Manufacturing Practice Annex 16
- Certification statement confirmation in accordance with Article 51 of Directive 2001/83/EC
- Reference to company internal systems (for example, global Enterprise Resource Planning system) that shows batch certification
- Confirmation that the final manufacturing step (other than batch certification) of an authorised medicine has been performed by a Manufacturing and Import Authorisation holder in a listed country
- For medicines authorised in a listed country, batch certification may be verified by confirming that the medicine has been purchased from an authorised wholesaler after it has been placed on the market in the listed country
Central Pharma HPRA GMP and GDP certificate confirms Central Pharma’s Irish operations pass regular GMP and GDP inspections for compliance.
When your finished product is ready it is shipped to wholesalers or distributors in countries where it has been QP released, either UK or a country in the EU. Central Pharma arranges transport to the customer in the UK or uses 3PL partners in the EU. They only use approved and audited transport providers for licensed medicinal products and controlled substances.
Central Pharma’s transport partners are GDP certified and can handle shipments requiring specific temperature conditions and provide a range of express and economy delivery solutions.
Not only do they provide import, manufacturing and UK/EU gateway services, they also offer a full range of consultancy services, including dedicated project management, QP batch release certification, regulatory support, site information and procurement.
Central Pharma’s experts help you navigate the complex and evolving regulatory environment to ensure your pharmaceutical and therapeutical products are imported and released correctly into the UK and EU marketplaces.
Partnering with Central Pharma offers you a gateway into the UK and the EU marketplaces, potentially generating significant new revenue streams for your business and strengthening your global brand equity.
They are there to guide you at every step, from shipping your product from your manufacturing site to finished product on the shelves of retailers in the UK and the EU, eliminating the headache of having to navigate the complicated, and often prohibitive, journey of taking your pharmaceutical and therapeutical products into lucrative new marketplaces.
Discover how partnering with Central Pharma can help you get your finished pharmaceutical and therapeutical products into UK and EU marketplaces and gain exposure to an extensive new customer base.View all news
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