Reporting of adverse events ONLY

Patients should always seek the advice of a doctor or pharmacist in case of adverse events.

If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:

00420 224 910 672

(from 09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

To contact us about any other issue please call:

+420 22 491 0000or our regional offices.

Hlášení nežádoucích príhod

Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.

Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:

00420 224 910 672

(09.00-17.30 CET)

00420 723 694 460

(non-stop 24/7)

Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:

+420 22 491 0000 nebo naše další pobočky.

MHRA sets its post-Brexit strategic direction

Last month, the Medicines and Healthcare Products Regulatory Agency (MHRA) released its 5-year corporate plan (2018 – 2023). Naturally, with Brexit fast approaching in the rear-view mirror, there has been much anxiety and uncertainty within the industry as to what direction the MHRA will plan to take. The plan outlines the agency’s strategic direction over the coming 5 years and includes a section on how they plan to ensure a smooth European Union (EU) exit under any scenario.

The agency is looking to place this plan as a key positioning piece in dealing with the outcome of the Brexit negotiations. The plan retains the same five areas of improvement, namely: protecting public health, supporting innovation, robust vigilance, safe production and supply, and exemplar of organisational excellence and efficiency. However, the new plan crystallises these areas now in clear objectives as opposed to nebulous aims. The agency plans to deliver on the five objectives by a set of actions, activities, and projects.
The new plan has been developed using internal agency staff and external industry input and, according to Sir Michael Rawlins GBE (Chairman of MHRA), looks to position the MHRA “to be agile to meet the changes which we know will lie ahead and to continue to deliver innovative science and first-class research.”

The plan outlines the progress that has been made since the previous 5-year plan and highlights key achievements in internal alignment and expertise, playing a key role in the development of standards and global collaboration. It then goes on to detail the key challenges faced by the agency – with the UK’s EU exit being the main one. Although the plan is still very sketchy on the details due to ongoing political wranglings, the agency seems to continue to be bullish in its belief that it will still play a major part in regulatory collaboration, pointing to already existing systems in Switzerland and Turkey. The agency is focusing on its key areas of strength, in particular its position as a global leader – as well as a pool of talent and expertise – to still remain a force within global regulation. This is further supported by the strategic vision for the next 5 years, which feeds into its core objectives.

It is clear that these are unique and challenging times for the agency, and it is imperative that companies stay abreast of the development of this plan so as to evaluate the agency’s ability to be the country of choice for future developments, advice and submissions.

To read the plan in full, please follow this link.