UK: MHRA's Guidance on TPD Compliance

First of all, for those of you who don't know this, MHRA stands for the Medicines and Healthcare products Regulatory Agency.  They have been selected as the agency with the ability and the proficiency to execute the conditions of Article 20.  Since that time, they have published a guidance to educate retailers, producers and consumers on the general specifics and the UK's special additions.  Here we will try and boil it down to the basics for you.

First, you should understand that the Tobacco Products Directive 2014/14/EU (TPD) has created ome new rules for electronic cigarettes containing nicotine and their refill containers (Article 20).  That is why MHRA is now involved.

MHRA's Guidance on TPD Compliance: Producers Defined

According to the authority the definition of a producer is 'anyone who manufactures or imports vapor products or who re-brands any product as their own.' This is the opposite of a retailer who only sells e-cigarettes and/or E-Liquids by retail to the general public'.  A retailer cannot also be a producer and neither can a producer be a retailer.

What E-Liquid Manufacturers Producers Need to Know

It is only producers who are obligated to notify MHRA concerning their products and also to use the European portal (EU CEG).  The TPD does not pertain to products which contain nicotine but are considered medicines.

However, a producer DOES NOT NEET to make a notification if:

  • a prior UK notification for the particular product you import has been submitted by the manufacturer,the manufacturer has already made notification of the details of a product that
  • the manufacturer has already made notification of the details of a product that you have re-branded

Afterwards, MHRA makes an assessment as to if the product notification has been finished in its entirety and complies with the TPD, then publishes all information which is non-confidential.  (What is deemed confidential is up to the producers to determine while the notification process is taking place).

MHRA requires notification 6 months before a new product is to appear in the UK market.  However, during the time of May 20 to November 19, 2016 new product applications must be submitted at least one day prior to their being sold for the first time.

It has further been established that a product which has undergone substantial modification will be considered a new product and will have to undergo this process.  This pertains to any change which can affect the human body and includes one or more of these:

  • if there is a change to the qualitative or quantitative composition of the nicotine-containing liquid;
  • if there is a change to the amount a refill container, tank or cartridge holds;
  • If there is a change to the make up or power output of a device that would probably affect emissions.

What E-Liquid and E-cigarette Vape Shop and Vape Retailers Need to Know

It is only necessary for a retailer to submit information for his products that are on sale if he qualifies as a producer. Retailers have until May 20, 2017 to sell their stock of products that don't meet the labeling and product composition requirements of the TPD.

Following this time period, between November 20, 2016 and May 19, 2017 a retailer is permitted to sell their left over stock, but needs to ask the suppliers if the products are in compliance with the rules of TPD, and whether or not the supplier notified MHRA about its products.

After May 20, 2017, no other products except for those that MHRA has been notified about will be permitted to be sold.  Check the MHRA website where all products that meet their standards are listed.

Cross-border Sales of E-Liquid and E-Cigarettes

Any business selling to consumers is required to be registered (be able to show a confirmation of registration) for cross-border distance sales (online sale) from May 20, 2016.  This includes for UK business -- European Economic Area (EEA, 28 Member states + Liechtenstein + Iceland + Norway).

Product Labeling: E-Liquids and E-Cigarettes

The government of the UK has defined the TPD rules for labeling products.  It especially explains the terms Unit Pack, Outside Packaging, Container Pack and also shows how to met European rules.

  • Producers are encouraged to place information on the bottle to identify the product and guarantee it can be safely used regardless of the fact that it is not a TPD rule, particularly if the bottle is in a cardboard.
  • Bottle of E-Liquid with no other type of packaging besides an information leaflet adhered to the bottle using a tag or other method.  The rules for labeling have to be applied to the bottle in some way, either by label, pull-out label or some other method.
  • Bottle of E-Liquid with information put into a cardboard box/sleeve.  This is the smallest form of individual packaging. The cardboard box/sleeve has to TPD labeling, but not the bottle itself.
  • Multipack consisting of two or more bottles of E-Liquid or E-Liquid in a   presentation box or starter kit -- Should the bottles be put in a cardboard box/sleeve, TPD labeling is required for both the cardboard box/sleeve and each (container pack).
  • In cases where the separate bottles are not packaged and are put in a multipack or presentation box, the multipack or presentation box would be thought of as the unit pack.  It would just be the multipack or presentation box that would need TPD labeling.

Reporting Problems

Starting May 20, 2016, producers are required to inform MHRA of any problems with a product (lacking quality, not safe or not meeting TPD regulations) and supply details of the potential risk to human health and safety.  Any actions taken to remedy this situation should be reported too.

Consumers are also able to get in touch with Citizens Advice in order to report any problems.  Plus, consumers and healthcare professionals are able to report any safety problems or side effects that occur with e-cigarettes or their refill containers to the MHRA through the Yellow Card reporting system.

Exempt from the TPD rules are products which have nicotine, but are authorized as medicines.

So far the rules and regulations appear not to be too difficult to follow, however, this may change as MHRA continues to evaluate and improve upon their rules and to more clearly define them.

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