HDA UK Media And Political Bulletin – 15 February 2017
MHRA Blog, Cheryl Blake, 14 February 2017
MHRA events in December 2016 discussed the Unified Customs Codes (UCC) and their latest article elaborates on this by explaining the central export procedures and requirements. The need to provide accurate and correct information on customs declarations is underscored. To facilitate this, export documentation must be carefully managed to prevent problems with poor control or lack of visibility within the supply chain. Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) will be routinely requesting full export documentation at inspection to support these measures.
The Pharmaceutical Journal, 13 February 2017
A website has been launched to inform community pharmacists about the introduction of the EU Falsified Medicines Directive (FMD). It outlines new authentication systems and dates of implementation, as well as offering information on how to implement changes. The UK database will be developed by SecurMed UK. Chair of the UK FMD working group for community pharmacy and dispensing entities director of SecurMed UK, said: “FMD aims to reduce [falsification] by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process”.
HSJ, Joe Gammie, 14 February 2017
Twenty-three trusts have been selected for the first phase of Lord Carter’s new review on productivity at mental health and community service organisations. The review will follow a similar format to Lord Carter’s previous investigation into hospital productivity. The engagement phase will include a focus on what ‘good’ looks like, how to drive existing efficiency measures, and what metrics and indicators are required to support the development of the model for these sectors. Benchmarking criteria for an ‘optimal model’ NHS community or mental health care trust will also be created.
There is no Parliamentary Coverage.
MHRA Blog, Cheryl Blake, 14 February 2017
Those of you who attended our symposiums in either Glasgow or London during December 2016 will have heard Jane Sewell – International Trade Development Liaison Officer from HMRC speak about the Unified Customs Code.
This is a major change in customs legislation affecting the international freight industry and businesses making customs declarations. The Union Customs Code (UCC) was introduced across the European Union on 1st May 2016 and consequently it introduced a number of changes to how goods cross EU borders. Jane spoke of the importance of providing accurate and correct information on customs declarations and also touched upon the Incoterm Ex Works and the difficulties of proving export has taken place when entering into trade agreements in this manner.
Those of you who are regular attendees at these events will have heard me speak on similar themes over the years. The changes brought about by the introduction of the UCC are important and far reaching and may have been new to many delegates and to many of you that may be reading this post.
Also at the symposium delegates heard a shocking, but interesting, presentation by my colleague Naseem Hudroge, Senior Intelligence Analyst, which gave further insight into the importance of getting customs declarations correct and also highlighted the need for you to be able to present such export documentation when it is asked for during an inspection. Both the MHRA and HMRC will expect these declarations to be correct, accurate and available.
In this, my first blog post, I shall attempt to put this information into context and to suggest ways in which you can actively prevent your company receiving deficiencies in the area of lack of documentation and poor control, or lack of visibility within the supply chain, simply by making small changes to and increasing your understanding of export procedures and requirements.
When exporting a medicinal product, a declaration must be made to HMRC to indicate exactly what is being shipped, who is making the shipment and where the product is ultimately going.
The product should be accompanied by a commercial invoice – proforma invoices are to be avoided as this can, and has led to misleading customs declarations being completed. A false declaration may result in seizure of the product and may also lead to a fine.
It is the responsibility of the exporter to enquire into the import and export regulations (any prohibitions, restrictions, trade embargoes, etc.) that may be in force in relation to the destination country. The exporter must ensure that certificates of origin, export licenses and the like which may be required in relation to the trade in the particular commodity within the destination country are applied for and that the correct documentation accompanies the shipment. Copies of this documentation should routinely be retained.
The exporter (consignor) is also responsible for ensuring that:
- medicinal products remain in the legal supply chain,
- export paperwork is correctly completed,
- proof of export is obtained and retained,
- the consignee is entitled to receive the product, and
- the product has been stored, handled and shipped in accordance with GDP.
Your freight forwarder or shipping agent is a key partner. It is best practice to routinely provide the freight forwarder, shipping department or freight agent with the following:
- your Economic Operator Registration and Identification (EORI) number
- details of whom the goods are to be consigned to (name and address in full)
- commercial reference to be incorporated into the Declaration Unique Consignment Reference (DUCR) to assist with export audit trails
- details of the country of final destination
- shipping or flight details
- correct value of goods in the correct currency code
- the Commodity Code and a clear and unambiguous description of the goods, their quantity, marks and numbers.
- any reference numbers already issued by HMRC – such as any previous declarations made in respect of the product. For example, the declaration made when the product was ‘introduced’.
Whilst on inspection, upon asking for documentation relating to an export to a third country we are frequently presented with invoices which show the Incoterm ‘Ex Works’. This generally causes issues at inspection as the consignor may have handed the product over for export to a representative of a company appointed by the consignee. Where this is the case, the consignor generally will be unable to demonstrate GDP compliance or indeed produce any paperwork showing the product has been exported as claimed. Companies should request copies of the documentation (which is interchangeably referred to as the SAD, C88 or export declaration) from their shipping agent and check this for accuracy.
The Incoterm EXW (Ex Works) puts the onus on the consignee to arrange the pre-carriage from the seller’s premises to the point of export, and to complete and pay for the export formalities. In most export scenarios this presents practical difficulties. Realistically for all export transactions the exporter needs to be involved in export reporting formalities and cannot realistically leave this to the consignee.
A lesser used but more practical Incoterm when an exporter does not wish to pay for the carriage of the product, is FCA – Free Carrier (named place of delivery). Generally the named place of delivery will be the port through which the product is leaving. With this Incoterm, the seller has control regarding the transport and customs formalities prior to the goods leaving the territory, and the buyer pays for the main transport.
Since it is the legal responsibility of the declarant to ensure that the goods are accurately declared when presented to HMRC, using this Incoterm gives the seller the control required. Crucially the seller also takes responsibility for arranging the transport to the point of shipment (or consolidation) and can therefore control where the goods are held and by whom prior to shipment, hence ensuring that the product remains within the legal supply chain and under GDP
control up to the point of main transport, which will have risk assessed according to Chapter 9 of 2013/C 343/01.
Both the GDP and GMP inspectorate will be routinely requesting full export documentation at inspection – and this extends to the CHIEF (Customs Handling of Import and Export Freight) entry – bills of lading or airway bills, export licences where applicable, and any certificates of origin that may be required for that particular commodity to be sent to the destination country. For exports we still expect that you can show the same due diligence.
Finally, I would like to leave you with the thought that, as the exporter, the responsibility in ensuring the information you provide to HMRC rests with you.
I intend to produce a second post during 2017 on the subject of introduction.
The Pharmaceutical Journal, 13 February 2017
A website containing information to help community pharmacists prepare for the introduction of the EU Falsified Medicines Directive (FMD) has been launched by the UK FMD working group for community pharmacy, which includes representatives of all the main bodies in community pharmacy.
The website’s aim is to help UK pharmacies prepare for whatever new authentication systems are developed and introduced, and has been tailored to reflect the way UK pharmacies operate, rather than a theoretical ‘European’ model.
Under the FMD, all new packets of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique barcode and an anti-tamper device.
The website says that it is likely that FMD scanning will come into effect before the UK leaves the EU. Any changes made to the 2012 UK Human Medicines Regulations to implement FMD would remain in place until the UK government decides to change them.
At present, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA), have stated that they are continuing with work to implement FMD in the UK and this is “business as usual” for them.
The UK database will be developed by SecurMed UK, a new organisation representing all the main supply-chain bodies for manufacturers, wholesalers and pharmacies. SecurMed UK represents pharmacy jointly with the National Pharmacy Association and the Company Chemists’ Association.
Raj Patel, a member of the National Pharmacy Association board, who is also chair of the UK FMD working group for community pharmacy as well as the dispensing entities director of SecurMed UK, comments: “Falsification of medicines is a major threat to patient safety and cases of falsification continue to be discovered by authorities. FMD aims to reduce this by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process.
“We recognise that this will be a big change for everyone in the medicines supply chain, especially community pharmacists. That’s why we’ve been working closely with the Department of Health
and the MHRA to ensure that this is implemented in a proportionate way that fully reflects the UK’s unique dispensing models.”
HSJ, Joe Gammie, 14 February 2017
More than 20 trusts have been chosen to be part of a new NHS efficiency review led by Lord Carter.
The Labour peer and a team from NHS Improvement will look into organisational productivity and performance at mental health and community service organisations.
In a letter seen by HSJ, NHSI said the review will follow a similar structure and methodology to Lord Carter’s previous investigation into acute hospital productivity, published last year.
The letter was written by NHSI director of sector development Luke Edwards, and was sent to all mental health and community trust chief executives and chairs last week.
It reveals the 23 mental health and community service providers that will begin six months of detailed engagement in the first phase of the review with Lord Carter and a team from NHSI’s operational productivity directorate.
From Factory to Pharmacy
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