What are the UK pack labelling requirements?
The UK pack labelling requirements are: - Product code in GTIN format - Batch Number - Expiry Date - Unique serialisation number - 2D matrix.
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- Introduction
- First Log-on: Quick Start Guide
- Customer Services
- I've received certificate access via email but no username by post as yet. How long does this normally take?
- I have received my credentials from SecurMed UK and installed the certificate but I am now having a problem logging onto my FMD software. What should I do?
- I have tried to reset my UK MVS password but have not received the reset email. What should I do?
- Has baseline testing been accepted for our provider?
- How long is my certificate available to download?
- How can I prevent my UK MVS account being locked?
- How does bulk registration for multiple locations work in the concentrator model?
- If you have 2 dispensaries in the same hospital, do they each need a certificate?
- Hospital pharmacies in Wales are not necessarily registered with GPhC. If not, which registration body should be used for End User Registration?
- Can an end user register several times but for different software suppliers?
- If you have wholly owned subsidiaries across the trust hospitals, do the individual subsidiaries need to be registered separately to the hospital it is located in?
- Is each GP a separate legal entity?
- Is it possible for software providers to register their list of customers without having a service agreement regarding the provision of the FMD service/software?
- Is the end user registration process scalable for 9,000 GP Practices across the UK, many with multiple Branch locations?
- Is there a specification for the format of the data returned for bulk registrations?
- One hospital has several 'goods in' locations. Is this a single or bulk registration?
- Our GP Practice has a main practice surgery and a number of branch surgeries. Which do I need to register?
- Overview of the SecurMed UK End-user Registration Process
- When using the bulk registration method for onboarding locations, can our organisation [software supplier] provide authorisation on behalf of all locations in a single notification?
- Which registers are going to be used to verify end user locations?
- Will a legal entity with multiple locations require a unique user ID and certificate per location?
- Will the certificate renewal email be sent to the requestor or the user at the location?
- With bulk registrations, will each location have a unique user id/ certificate for us to access against the corresponding location?
- Registration process for Wholesalers, Hospitals & Pharmacies
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- Introduction
- I am an End-user. How do I register with SecurMed?
- I am a Community Pharmacist; where can I find more information on FMD specifically related to my sector?
- Can Pharmacists still dispense the product to patients without serialisation after 9th of February 2019?
- Customer Services
- Falsified Medicines Directive (FMD) Case Studies
- First Log-on: Quick Start Guide
- Who can see/use FMD information in the pharmacy?
- Will a legal entity with multiple locations require a unique user ID and certificate per location?
- Will manufacturers and wholesalers be able to see data on products I have dispensed?
- Will pharmacies be able to return stock to their wholesaler or a DTP manufacturers’ distributor?
- Registration process for Wholesalers, Hospitals & Pharmacies
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- Introduction
- I am an End-user. How do I register with SecurMed?
- Can Pharmacists still dispense the product to patients without serialisation after 9th of February 2019?
- Customer Services
- Falsified Medicines Directive (FMD) Case Studies
- First Log-on: Quick Start Guide
- I operate within the Secondary Care sector; where can I find information about FMD specifically related to my sector?
- Who can see/use FMD information in the pharmacy?
- Will a legal entity with multiple locations require a unique user ID and certificate per location?
- Will manufacturers and wholesalers be able to see data on products I have dispensed?
- Will pharmacies be able to return stock to their wholesaler or a DTP manufacturers’ distributor?
- Registration process for Wholesalers, Hospitals & Pharmacies
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- Introduction
- Where can GPs get further information?
- I am an End-user. How do I register with SecurMed?
- Are out of hours GP services included within the scope of FMD?
- Can Pharmacists still dispense the product to patients without serialisation after 9th of February 2019?
- Dispensing doctor end-users have been informed by the DDA not to commit to any SSPs currently (15/11/18)?
- Customer Services
- First Log-on: Quick Start Guide
- Registration process for Wholesalers, Hospitals & Pharmacies
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- Introduction
- First Log-on: Quick Start Guide
- Can Pharmacists still dispense the product to patients without serialisation after 9th of February 2019?
- Can pharmacy and wholesalers sell data to IMS?
- If stock is transferred from one nominated site to another, does the receiving nominated site have to do full checks of the stock received?
- Why is the mixed-bulk transaction not available to wholesalers?
- Will a wholesaler performing QP batch release against the manufacturers MA and then wholesales these products under a WDA to hospitals, pharmacies and GPs, need to register with SecurMed UK?
- Will veterinary wholesalers need to comply with the FMD regulatory requirements?
- Registration process for Wholesalers, Hospitals & Pharmacies
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- I am a Manufacturer; where can I find more information?
- A manufacturer has a WDA as does its' 3rd party logistics provider (3PL). The 3PL was intending to decommission medicines on behalf of the manufacturer but the manufacturer wants to do all decommmissioning
- Are EMA Marketing Authorisations the same as UK MHRA Marketing Authorisations?
- Are the MAH Setup Fees inclusive or exclusive of VAT?
- Can you confirm what relationship a wholesale dealer needs to have with the MAH to allow them to be registered as a designated wholesaler for that MAH. Does it have to be a 3PL relationship?
- Does the GTIN product code for UK require 13 characters or 14 characters?
- How do manufacturers (MAHs) who also hold a WDA register with the SecurMed UK contracting process for connectivity of the wholesaling FMD/DR functionality required under?
- How does my company apply for the Micro MAH fee waiver?
- How is the FMD enforced?
- How will Brexit affect the Falsified Medicines Directive and its' processes?
- How will medicines originally destined for one market but then sold to another market under an Art.126a/Exceptional MA be handled?
- How will SecurMed UK count the number of Marketing Authorisation Holdings?
- If a product is manufactured outside the EU and batch released in the UK, who will be responsible for releasing the serial number in the HUB and when?
- Is it possible to convert EAN codes to GTIN by adding 0 at the beginning of GTIN or new GTIN will be issued?
- Is the Product Code (PC) taken obligatory from the Agency or it can be taken from MAH internal database assigned by GS1?
- MAH Agreement
- MAH Registration Form
- Our company needs to affiliate to GS1, is SecurMed the company to contact for this?
- The MHRA wrote to companies in 2014 asking for products to put forward for the White List which would be exempt from the FMD changes. As we were not aware of the letter at the time we did not submit any products. Can products still be added to the White List?
- We are a manufacturer of medicines and have multi-market packs labelled and supplied to UK and Ireland. Will the EMVS and NMVS system cater for this?
- We are a Marketing Authorisation Holder who have an active MAH for UK but we do not market any medicines here at the moment. Are we required to contract with SecurMed UK and pay fees for the UK system?
- What is the process for onboarding to FMD?
- Where can I find information about packaging and labelling changes as a result of FMD?
- Where the MAH/manufacturer has a separate WDA will the warehouse need to be linked in to the UK MVS for decommissioning of packs or will this be done via an MA holder/manufacturer link?
- Who is responsible for implementing serialisation when an MAH is manufacturing and supplying �?own label suppliers’?
- Who is responsible for implementing serialisation when an MAH is manufacturing and supplying �?own label suppliers’?
- Will there be any requirement for the WDA holder to have an interaction with the EMVS?
- Will there be interaction between the UK national hub and each MAH for downloading pack data?
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- National Health Registration Number (AMPP) - Mandatory for the UK
- Client Transaction ID (ClientTrxID) Length
- Are there technical standards to which the 2D codes should conform?
- As a Software Supplier, how do I register for the Arvato developers toolkit (SDK)?
- Can a single location have multiple sets of credentials for different software solutions?
- Can an end user test a software supplier’s system without committing to a supplier?
- Can the initial certificate download be done via the web service?
- Can you confirm the master data (Message G101) allows the software provider to differentiate between FMD and non-FMD products?
- Certificate & Password Management Issues
- Certificate Error in Google Chrome
- Do SecurMed UK publish a list of Approved Suppliers?
- Do we need to implement bulk transactions in our Wholesaler software?
- Document FD-002 talks about the T&C's web service. Can the portal be used to accept the revised version or only via the web service?
- Does resetting the password also require a new certificate?
- Does the master data (G101 Process) allow the software provider to differentiate between FMD and non-FMD products?
- How do I change my initial password?
- How do I register as a software supplier for the UK?
- How do I test my end-user software solution and verify it is ready to connect to the UK MVS?
- How long is my certificate available to download?
- I am an End-user. How do I register with SecurMed?
- I am an IT Company who supplies FMD software for manufacturers. Where do I register?
- I am designing my software solution connection to the NMVS. Are Concentrator/Aggregator type architectures acceptable in the UK?
- If baseline testing has already been completed in interface v2, will it need to be redone in v3?
- If the Product is unknown in the UK MVS, does the UK MVS extend the request to the wider EMVS?
- Initial Production MVS Setup Guidelines
- Invalid Date Errors
- Is IMT in the scope of baseline testing?
- Is multi-factor authentication required?
- MVS Roadmap 2019
- Pack Coding Guidelines issued by EMVS
- Should I add a sub-user ID?
- The Arvato toolkit only allows one certificate per developer, is there a way to get a group or enterprise level certificate?
- UK MVS Configuration
- What are the mixed-bulk transactions?
- What do I do when the NMVS returns an Alert?
- What is the certificate renewal process?
- What is the password expiry period?
- While the "Concentrator" approach is not acceptable, Arvato's initial "Cumulator" concept will still be acceptable for a few terminals in a SINGLE location
- Why is it essential to present a unique certificate as well as a unique username and password?
- Why is the mixed-bulk transaction not available to wholesalers?
- Will the current version endpoints be available for testing purposes following the release of new endpoints?
- Will the endpoints be different for new versions of the interfaces?
- EMVO Letter of Announcement 7 August 2019: Emergency fix for the EU Hub IQE environment
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- Alerts Reporting
- EMVO Announcement: 21 August 2019 Alert Message Formats
- Guidance on FMD Errors or Alerts
- EMVO Letter of Announcement 17 July 2019: Alert Propagation
- Is there further guidance on False Negatives - out of date, recalled pack, status error, data error, etc?
- What do I do when the NMVS returns an Alert?
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- EMVO Newsletter 5 July 2019
- EMVO Announcement: 21 August 2019 Alert Message Formats
- EMVO Letter of Announcement 20 August 2019: EU Hub Release 1.4.08 restoration – planned downtime
- EMVO Letter of Announcement 7 August 2019: Emergency fix for the EU Hub IQE environment
- EMVO Letter of Announcement 17 July 2019: Alert Propagation
- EMVO Letter of Announcement 12 July 2019: EU Hub Release 1.5 documentation and IQE Deployment
- EMVO Letter of Announcement 28 June 2019: EU Hub Release 1.5 technical documentation
- EMVO Newsletter 21 June 2019
- EMVO Statement 20 June 2019: Parallel Distributor MAH name field
- EMVO Newsletter 07 June 2019
- EMVO Statement 6 June 2019 - Release 1.5 of the EU Hub
- EMVO Newsletter 24 May 2019
- EMVO Newsletter 26 April 2019
- EMVO Announcement 26 Aug 2019: Restoration of the EU Hub IQE environment to Release 1.4.08
- EMVO Letter of Announcement: 06 Sept 2019 OBP/MAH Information Security
- EMVO Letter of Announcement 10 Sept 2019 : EU Hub Release 1.6
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- Safety Features For Medicinal Products For Human Use Questions and Answers Version - 15
- First Log-on: Quick Start Guide
- Pack Coding Guidelines issued by EMVS
- Customer Services
- Guidance on implementing FMD Safety Features on GOV.UK site
- How is the FMD enforced?
- Are EMA Marketing Authorisations the same as UK MHRA Marketing Authorisations?
- Can �?soft-wrap (e.g. cellophane) bundle of packs be labelled with an individual label showing the UK pack labelling requirements above?
- Who is going to pay for software and hardware changes in healthcare institutions, pharmacy and wholesaler systems - and how much will it cost?
- A manufacturer has a WDA as does its' 3rd party logistics provider (3PL). The 3PL was intending to decommission medicines on behalf of the manufacturer but the manufacturer wants to do all decommissioning itself in the EMVS using its WDA. Is this allowed?
- Does the UK Regulator, the MHRA produce guidance and advice on FMD?
- Community Pharmacy
- Are medical devices in the scope of serialisation?
- Has baseline testing been accepted for our provider?
- Do dental pharmaceuticals companies, dental wholesalers or dentists need to comply with the FMD regulatory requirements?
- Does FMD apply to clinical trials materials? If an existing licensed drug is used in a clinical trial, when would it need to be decommissioned?
- How does a company affiliate to GS1
- How does the EMVS and UK MVS cater for manufacturers of medicines with multi-market packs labelled and supplied to UK and Ireland?
- Does Article 37(d) require that a National Medicine Verification Organisation (NMVO) directly alerts the relevant national competent authorities, the EMA and the Commission about a falsification? Is there is a time limit for such alerting?
- How long is my certificate available to download?
- How many manufacturers are now supplying codes to SecurMed UK?
- How should serialisation be implemented for �?titration’ packs, only to outer box or it should also be applied to the inner boxes too?
- How will Brexit affect the Falsified Medicines Directive and its' processes?
- I am a biopharmaceutical manufacturer operating within the research sector; where can I find more information about FMD?
- I am a European Parallel Distributor/Importer; where can I find more information?
- I am an IT Company who supplies FMD software for manufacturers. Where do I register?
- If a product is manufactured outside the EU and batch released in the UK, who will be responsible for releasing the serial number in the HUB and when?
- If stock is transferred from one nominated site to another, does the receiving nominated site have to do full checks of the stock received?
- Is aggregation data available in the NMVS/EMS?
- Is aggregation permitted, in particular for use of downstream wholesalers?
- Is Gibraltar in scope of the FMD implementation and what about British Crown Dependencies and British Overseas Territories?
- Is supply-side aggregation only being considered for hospitals?
- Is there any order that the text has to appear in the 2D Matrix or as �?human readable’ on the pack?
- NHS England
- NHS FMD Toolkit
- Overview of the SecurMed UK End-user Registration Process
- Secondary Care
- We have a radio-pharmaceutical MA that is a POM medicine, do we need to register with SecurMed UK?
- What are the UK pack labelling requirements?
- What happens in the result of a negative response to a pack scan?
- What is PEPPOL, and is there a relationship to FMD?
- What is scan4safety, and is there a relationship to FMD?
- What is the definition of a Healthcare Institution in scope of FMD for the UK
- What is the difference between decommissioning and verification?
- What is the EMVO and how can I contact them?
- What is the password expiry period?
- What is the position related to FMD for clinics / Health Centres e.g. abortion clinics?
- What is the process for dispensing if the system goes down and we queue up messages? Are we expected to withhold all medicines until the items are verified and dispensed through the mixed bulk transactions?
- Where can GPs get further information?
- Where can I find a copy of the Delegated Regulation?
- Where can I find information about packaging and labelling changes as a result of FMD?
- Where can I find the EU Commission Q&A on FMD?
- Where can I get more information of the safety features aspects of FMD?
- Which medicines are in scope of FMD?
- Who is responsible for implementing serialisation when an MAH is manufacturing and supplying �?own label suppliers’?
- Who will have to decommission homecare supplied drugs?
- Will anti-tamper devices be allowed on OTCs and other out-of-scope products after February 2019?
- Will FMD compliant packs only have the 2D barcode? (Therefore, by default, non FMD packs will have the 1D barcode and not require scanning?)
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