As we approach the May 2017 deadline manufacturers can expect to hear back from the agencies such as the MHRA regarding their submitted notifications. This might be in the form of a letter, email or a telephone call. But why might an agency contact a manufacturer?
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The reasons the MHRA might engage with a manufacturer can vary but are likely to fall into one of the following categories:
Although the notification submission software provided by the European Commission includes an automated validation stage to ensure mandatory fields are completed before submission, an agency may request data relating to non-mandatory fields – such as mode of sales or declaration of high purity – after submission.
Under TPD, agencies are required to ensure manufacturers are following a set of rules including: ingredients of high purity are used in the manufacture of e-liquid (Article 20.3.d). However, due to the design of the software, notifications can be submitted with the high purity field left unchecked meaning agencies may decide to request confirmation post-submission. This is indeed what we have seen with the latest communication to manufacturers from the UK health authority, the MHRA.
Misinterpretation of guidance
Draft guidance was published in the run up to the November deadline. Given the fact that some guides were slightly vague in detail we can expect a wide range of interpretations. Where a manufacturer’s interpretation does not meet the agencies’ interpretation we are likely to see agency requests for clarification or more information.
From conversations with manufacturers, we understand a key area is likely to be the requirement for e-liquid composition (ingredients and quantities) and toxicology information on ingredients. The agency may consider the data insufficient or irrelevant (see also Tox requirement). With regards to the description of the test method for e-cigarette testing, agencies could ask to see greater detail or more comprehensive emissions data.
Some agencies – about half of the EU markets – charge for a notification including UK and France (there is no fee for notifications in Germany and Netherlands). Manufacturers can expect to hear from agencies that have chosen to charge for a notification. Fees for notification form part of the country-specific requirements – read more about country-specific requirements here.
The devil’s in the detail
It is as yet unclear to what extent agencies will scrutinise the submitted information in their checks for TPD compliance. Over the next few months we will start to get an idea. Manufacturers can prepare by ensuring that they have a quick and easily way to see what information has been submitted in their notifications via a database or other means (this is particularly important for e-liquid manufacturers with vast range of products). Preparation now will facilitate a quick response to a request for information by an agency.
How can Medic Pro help?
Our knowledge of the regulations, market-specific requirements and experience with working with agencies enable us to help our clients understand and respond to any requests for information quickly and effectively. Should you receive a communication from an agency and require support please do not hesitate to contact us.
Tens of thousands of notifications have been reportedly submitted since the notification portal came live last year.
Article 20.9 states that Member States may request additional information which relate to the ‘safety and quality aspects’ of notified products.
We understand that manufacturers that have made notifications in the UK but have not received a letter from the MHRA may receive one in due course.