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FMD Q&A - VWV Pharmaceuticals & Life Sciences Image

FMD Q&A

Falsified Medicines Directive Questions & Answers

At VWV's recent PING seminar on Falsified Medicines Directive, Paul Ranson spoke about the key provisions in the Falsified Medicines Directive and what is changing.

People have asked some excellent questions about FMD and its implementation. We did not have enough time at the PING Seminar to answer all of the questions that people have asked, and others have asked further questions since.

We are therefore running a series of FMD FAQs.

First Edition:

  1. When does FMD come into force?
  2. What effect is Brexit going to have?
  3. What if something is a GSL product in a European country, but it is a prescription only medicine in the UK?
  4. Does FMD cover high strength food supplements that are prescribed by doctors for treating conditions?
  5. Will the safety features apply to grocers ie non-pharmacies?
  6. Will the cost for scanners and software at pharmacy level be paid by the pharmacy or someone else?

Second Edition:

  1. What do the safety features consist of?
  2. Do the new requirements for safety features replace the usual requirements for labelling etc.?
  3. Is there detailed guidance on anti-tampering requirements?
  4. Can medicinal products currently bearing an anti-tampering device on a voluntary basis maintain the anti-tampering device after 9 February 2019?
  5. Can the unique identifier and the anti-tampering device be implemented in two steps during the transitional period?
  6. How will the packaging changes resulting from adding unique identifier and the anti-tampering device involve variations to marketing authorisations?

We hope you find this useful. Please let us know if you have any comments on this feature, or if you have any questions that you would like answered.


First Edition

1. When does FMD come into force?

They apply as of 9 February 2019. Belgium, Greece and Italy have the option of deferring the application of the rules by an additional period of up to six years.


2. What effect is Brexit going to have?

In February it was reported in the pharmaceutical press that Martin Sawer, Executive Director of the Healthcare Distribution Association and a speaker at the 4 July PING seminar, stated that the UK government has confirmed that Brexit will not put a stop to its plans to implement the EU’s Falsified Medicines Directive (FMD).

As far as safety features are concerned, however, there does seem a likelihood that the UK might not be ready for the February 2019 deadline given the uncertainties and the distractions. Moreover, we have all been made well aware that we leave the EU at the end of March 2019, barely a month later. However, on 4 July, the UK Government (or one element within it) issued a public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety. The statement, published in the Financial Times, by the Secretary of State for Health and Secretary of State for Business, Energy and Industrial Strategy, laid out the three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices:

  1. patients should not be disadvantaged
  2. innovators should be able to access the UK market as quickly and simply as possible
  3. the UK will continue to play a leading role in both Europe and the world in promoting public health.

Conversely, if things change and Brexit hardens, once the UK has actually left the EU there might be a gradual shift in the UK’s relationship with European regulators. Currently, Britain has considerable influence on the pharmaceutical industry through its role in a number of EU bodies and committees. Leaving the EU will mean losing its seats in those committees. As far as safety features go, if the UK decides to go it alone as to requirements regarding serialization, coding and aggregation, pharmaceutical companies and contract manufacturers face a potential nightmare in having to adapt to yet another set of requirements while they are already scrambling to meet the 2019 FMD safety feature deadline. Aside from the safety features, those already complying with the other provisions of Directive already in force including the supply chain and internet pharmacies, could face the issue of dealing with a new set of UK laws possibly inconsistent with the FMD.

However, the obvious prudent approach would be to continue to prepare on the assumption that the safety features and the rest of the FMD will be into force as currently anticipated.

Things are forever moving in this space and it is worth watching carefully. We will continue to keep people updated in this feature as and when there are further developments.


3. What if something is a GSL product in a European country, but it is a prescription only medicine in the UK?

The requirements relate to products 'subject to prescription'. As the data is collected at national level repositories this would suggest that it is the supply status in the country of dispensing that matters so a prescribed product in the UK would be covered regardless of its status in another EU country.


4. Does FMD cover high strength food supplements that are prescribed by doctors for treating conditions?  

The wording used in the FMD is of products 'subject to a prescription'. Therefore whilst I have seen no official confirmation on this point either way, this is different to 'prescription only' so where a product can (rather than must) be prescribed then such prescribed products would seem to be covered. It would be helpful to see confirmation of this point one way or the other.


5. Will the safety features apply to grocers ie non-pharmacies?

The FMD only applies to medicinal products subject to prescription. Other than for OTC omeprazole, over the counter (OTC) medicines will only need to be scanned if there is evidence of them being subject to counterfeiting. In these circumstances they will appear on a 'black' list.


6. Will the cost for scanners and software at pharmacy level be paid by the pharmacy or someone else?

The costs of establishing the database is to be borne by manufacturers of branded and generic medicines and parallel distributors though additional licensing fees. Pharmacies and wholesalers will be responsible for making their connections to the database, as well as for software upgrades.


Second Edition

1. What do the safety features consist of?

From 9 February 2019 medicinal products subject to a prescription must bear safety features facilitating the identification and authentication of the medicinal products and determining whether the packaging of a medicinal product has been tampered with. 

The unique identifier must be encoded in a two-dimensional barcode and must at least contain the:

  • product code allowing the identification of the name, the common name, the pharmaceutical form, the strength and the pack size
  • printed serial number, which is a numeric or alphanumeric sequence of a maximum of 20 characters
  • batch number and expiry date.

The product code, the serial number (and the national reimbursement number, if any) should be printed on the packaging in human-readable format, adjacent to the two-dimensional barcode.


2. Do the new requirements for safety features replace the usual requirements for labelling etc.?

No. The new requirements for safety features introduced by the regulation on safety features apply in addition to the usual requirements for labelling etc. The manufacturer is responsible for ensuring that the medicinal products covered by the requirements bear the safety features. The marketing authorisation holder continues to be responsible for the medicinal product and for ensuring that the labelling of the medicinal product meets the rules applicable from time to time. However the two-dimensional barcode will replace the existing EAN barcode.


3. Is there detailed guidance on anti-tampering requirements?

The law simply requires that on the outer packaging of a finished product (or, where there is no outer packaging, on the immediate packaging) there should be a device allowing verification of whether the outer packaging has been tampered with. The choice of tamper-evident feature to be used will be for the marketing authorisation holder to decide.  However further guidance is provided by CEN standard EN 16679/2014: “Tamper verification features for medicinal product packaging”, which describes the scope of application, the requirements and features of tamper-proof pharmaceutical packaging. 

The information provided by this standard primarily serves as guidance to pharmaceutical manufacturers with respect to testing the suitability of seals, and lays down the following requirements:

  • the tamper-proof seal must not impair the readability of the prescribed information
  • the prescribed packaging text must remain readable after the pack has been opened
  • the application of features to check tampering attempts may lead to an increase of the physical force required to open the packaging but must not substantially aggravate handling and opening the pack
  • the use of opening aids, such as special perforations or starter tabs, may be necessary

4. Can medicinal products currently bearing an anti-tampering device on a voluntary basis maintain the anti-tampering device after 9 February 2019?

Once Regulation (EU) No 2016/161 applies, medicinal products can only bear an anti-tampering device if they are subject to prescription or if the Member State(s) where they are placed on the market exercise their option to extend the scope of the anti-tampering device to those medicinal products.


5. Can the unique identifier and the anti-tampering device be implemented in two steps during the transitional period?

Yes it can be done in two steps, but everything has to be in place on 9th February 2019.


6. How will the packaging changes resulting from adding unique identifier and the anti-tampering device involve variations to marketing authorisations?

The regulatory requirements to be followed to notify the EMA of the placing of the unique identifier and/or the anti-tampering device on centrally authorised products are found here

The regulatory requirements for nationally authorised products are available here.


For more information, please contact Paul Ranson in our Pharmaceuticals & Life Sciences team, on 01923 919 346.

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