Pharmafreight held its AGM in October in Barcelona this year. The annual meeting of Pharmafreight licensed partners is held one day before the start of the annual CPhI global pharmaceutical meeting place exhibition. This year’s AGM and presentations dealt with the ongoing GDP audit roll-out of all global Pharmafreight partners to a common standard.
Pharmafreight is pleased to announce it now holds an MHRA Wholesale Dealer’s Authorisation, allowing it to store and transport medicines through its London Heathrow site.
Following a successful application and subsequent audit from the UK’s health regulator, the MHRA (Medicines and Healthcare products Regulatory Agency), Pharmafreight is now one of only a handful of UK freight companies that holds a Wholesale Dealer’s Authorisation (WDA), allowing it to store medicinal and related products at its temperature-controlled facility in Ashford, Middlesex, just outside London Heathrow Airport. The WDA also confirms Pharmafreight complies with the new Good Distribution Practice (GDP) Guidelines, designed to ensure that patient safety is upmost in a company’s mind, and that the efficacy of a drug is not affected whilst in a licence holders’ care.
Pharmafreight started working in the pharmaceutical forwarding industry back in the 1990’s through its parent company, Mach II Shipping. At that time it was relatively unheard of for a freight forwarder to understand and work to the regulations that pharmaceutical companies had to abide by. Having identified a gap in the market for a specialist freight forwarder dealing only in pharmaceuticals, the Pharmafreight division and brand was established, recruiting like-minded overseas freight companies into its own network, all designed to work to GDP.
During the European Commission’s consultation period last year on the new GDP Guidelines, it was initially suggested that any company in the supply chain holding product for more than 24 hours would need to have a WDA, which would have meant that any airline, transport or warehouse company could potentially need a licence. However this was eventually watered down so that a licence holder must only “minimise” the amount of time that its product is in an unlicensed facility. Despite this Pharmafreight decided that it still wanted to demonstrate to the pharmaceutical industry its aim to be associated with quality in the supply chain, and applied for a WDA licence anyway. Its successful application means that Pharmafreight can now store medicines at its facility for longer than a day, in accordance with GDP, and in the right temperature and quality conditions.
Andy Hughes, Commercial Director at Pharmafreight, said: “We are very pleased to be only one of a handful of independent freight forwarding companies that holds a Wholesale Dealer’s Authorisation in the UK. Pharma companies using our services can take some comfort that we are working to exactly the same legal requirements they are, fully compliant in GDP. And we apply these standards whether we are storing a product on a customer’s behalf, or indeed transporting a shipment halfway across the world.”
For further information about Pharmafreight and its services, please visit www.pharmafreight.com or e-mail info@ pharmafreight.com
Pharmafreight is very pleased to announce the appointment of Geo Express International as its latest licensed partner, looking after Canada for the Group.
Pharmafreight has known Geo Express for a while now, and it has a good reputation in the clinical trial logistics market. It has been in operation since 1979 and specialises in several niche markets, including Health Sciences. Its specific offerings include:
– 24/7/365 door to door transportation of time and temperature sensitive material worldwide
– Clinical Trial Logistics of IMP, ancillary supplies and biological samples for safety/efficacy testing as well as for PK, PG, PD and biomarker assessments
– CTM depot services for drug storage and distribution (ambient, refrigerated and frozen)
– Cold Chain Management including packaging validation and provision/replenishment of refrigerants, packaging, and data loggers
– Health Canada Classified Distributor under HPFB Inspectorate GMP guidelines
– Health Canada Establishment License for the importation and distribution of Pharmaceuticals, NPNs, and Medical devices
– Canada Customs (CBSA) Bonded Warehouse License for temp-controlled imports specific to the Health Sciences industry
For further information please visit www.geoexpressinternational.com/health-services.html
If you have any requests for Canada please e-mail info@pharmafreight.com at this time.
Pharmafreight is very pleased to announce the appointment of a new partner to look after Denmark, Finland and Sweden.
Following a successful onsite visit to its operation in Copenhagen, Denmark, Pharmafreight has appointed the Finnish CHS Group – incorporating the AirLog Group in Denmark and Sweden – as its new partner for the region. The company has already been working in the clinical trial sector for several years now, providing temperature-controlled packaging and data loggers for its clients, as well as know-how on how to conduct clinical trials and handle pharmaceutical logistics. The company has completed Pharmafreight’s pre-application process, where all of its operations are audited against the new GDP Guidelines, before being appointed to the network. The company’s staff will now be required to undertake further GDP training via Pharmafreight’s online training centre.
For further information about CHS and AirLog, please visit the country pages on this website, or e-mail info@pharmafreight.com
Following the US Government shutdown last week, some consignments being moved into the US have felt the affects of the reduced services now being operated by many of the border agencies involved. What follows is a brief update on governmental services affecting the trade community after nearly one week of the government shutdown. The information provided is a general statement on the state of affairs within the mentioned organization–some government services are performed inconsistently throughout the nation depending on local circumstances.
CBP
Customs and Border Protection is retaining 88% of its personnel. There should be no impact on entry processing unless the merchandise is subjected to other agency approval.
CBP’s website is not actively being managed during the shutdown. Delays can occur in processing cancellations, deletions and corrections. Client representative offices are closed. The Revenue Division Bond Filing Section will continue to process bond requests but expect delays due to the reduced amount of personnel.
FDA
Most FDA offices report that processing import documents, examination and sampling of merchandise is unaffected by the government shutdown. Outreach programs is an area have been affected by the lack of funds.
APHIS
APHIS is only accepting select permits- Permits 525, 526, 546, 585, 586, 587, 588, and 621 through its ePermits website. USDA is not accepting mail at the current time so any permits sent through the mail will not be processed until the budget issue has been resolved.
EPA
EPA offices are closed.
Federal Maritime Commission
The FMC offices are closed. The FMC’s databases will not be accessible during shutdown. The Commission’s website will be available during the shutdown but will not be updated until operations resume. The Commission will not accept online filings or applications for Service Contracts, OTI applications or Tariff Registration Forms. The Commission’s online databases will not be accessible.
Fish & Wildlife
The eDecs system is down due to the lapse in appropriations. Therefore, all Fish and Wildlife documentation must be submitted in hard copy to the appropriate Fish and Wildlife office, including form 3-177. Delays will likely occur in processing the documentation.
BIS
Bureau of Industry and Security (BIS) is no longer accepting license applications or classification requests
FSIS
FSIS will continue to operate as normal.
International Trade Commission
The website containing the Harmonized Tariff Schedule of the U.S. is not accessible.
For more detailed and live information please e-mail info@pharmafreight.com
Pharmafreight has now confirmed its attendance at this year’s IQPC Cold Chain GDP & Temperature Management Logistics Global Forum, taking place in Chicago over 01st October through to 04th.
The well supported event brings together companies wanting to meet specialists in the pharmaceutical transportation field, sharing ideas and knowledge, ultimately aimed at improving all of the processes involved, and increasing the awareness of GDP and its requirements. Pharmafreight will be on hand at the Unitrans Intl Corp stand, its US partner. If you are also planning to attend please do stop by and say hello.
The MHRA (Medicines and Healthcare products Regulatory Agency) has announced that it seized a record £12.2 million of counterfeit and unlicensed medicines in the UK. This was part of a week-long international crackdown on the illegal internet trade of medicines that seized over £26.8 million globally.
The crackdown – called Operation Pangea VI – was conducted between 18 June and 25 June and resulted in 58 people being arrested worldwide. This operation has also resulted in 9, 610 illegal online websites that were selling counterfeit and unlicensed medicines being closed down or suspended through domain name or payment facility removal. Coordinated by INTERPOL and carried out by 99 countries across the globe, the operation targeted the three main elements misused in the illegal website trade – the internet infrastructure, the electronic payment system and the mail delivery service. Internationally, preliminary results show that more than 522,000 packages were inspected by regulators and customs officials resulting in the seizure of over £9.9 million doses of unlicensed and counterfeit medicines worth approximately £26.8 million.
In the United Kingdom, enforcement officers from the MHRA, with assistance from the Home Office UK Border Force and local police, raided addresses in connection with the illegal internet supply of medicines. This activity resulted in more than 3.7 million doses of unlicensed medicines worth approximately £12.2 million, including 97,500 doses of counterfeit pills being seized in the UK worth £525,000. The types of medicines the MHRA found were those for slimming, hair loss and erectile dysfunction.
The MHRA’s Acting Head of Enforcement, Nimo Ahmed, said: “During one week we have seized £12.2 million worth of counterfeit and unlicensed medicines. These were being stored in unacceptable conditions and supplied through illegal internet websites without prescriptions by people who are not qualified to dispense medicines. When people buy medicines from an illegal website they don’t know what they’re getting, where it came from or if it’s safe to take. The dose could be too high or too low, or the ingredients could break down incorrectly in the body which makes the medicine ineffective. They could also become victims of credit card or identity fraud as well as downloading computer viruses. We have closed down 1288 of these illegal websites but people need to take the time to see their GP about any problems they have with their health. People are far more likely to get better faster if they are on the correct course of safely prescribed medication.”
This year’s closure of illegal websites follows on from last year when approximately 18,000 illegal pharmacy websites were shut down through domain name or payment facility removal. A representative from Home Office UK Border force said: “The work carried out by Border Force officers as part of this joint operation makes clear just how seriously we take the smuggling of fake and unlicensed medicines. Smugglers are only out to make a profit. These goods are often dangerous and the proceeds can be used to fund serious organised crime.”
The Royal Pharmaceutical Society’s Neal Patel, said: “It is hugely worrying that prescription medicines are available from illicit websites. This is a serious patient safety issue. Not only is supplying prescription only medicines without a prescription illegal, it means that the user has no information about the ingredients, dosage instructions, or potential side effects, so patients would not be receiving proper healthcare advice. We would urge the public if they wish to buy medicines online to always check that they are dealing with a genuine pharmacy.”
If someone suspects their medicine may be counterfeit, contact the MHRA’s designated 24-hour anti-counterfeiting hotline on 020 3080 6701 or counterfeit@mhra.gsi.gov.uk.