10 Questions You Need To Consider When Moving from A DCP Close Out To Product Launch

When a Decentralised Procedure (DCP) or a Mutually Recognised Product (MRP) process is drawing to a close, much of the emphasis is placed on the getting a “positive opinion”. However, it is at a time like this, when submitting the final sequences that the focus on what comes next often gets lost. Time and again, companies close out their regulatory procedures only to be ill prepared for the national phases and the product launch.

The matter of completing national phases in each country and registration with the local health authorities can prove to be difficult and can significantly delay the launch of a product.

So, what preparatory work should be done upfront to avoid this?

10 Questions Decentralised procedure Close Out10 Questions You Need To Consider When Moving from A DCP Close Out To Product Launch

We have produced a list of 10 questions that need to be asked as you move towards the end of the procedure.

  1. What strengths and presentations are going to be launched in each market?
  2. What are the pricing procedures for each market you intend to launch in?
  3. Have you confirmed the product livery for each market?
  4. Have you started the translation process?  Start the translation process mid-way through your regulatory procedure (if you wait until the end it will be too late). This may result in slightly increased cost but it saves time and effort over the course of the project.
  5. Do you understand what the artwork “blue box” requirements for each country.
  6. Have you assessed if all of your text will fit?  If your product is eventually going to be marketed in multilingual packs make sure you have assessed if all the required text will fit. If it doesn’t fit, you may need to apply the reduced labelling guidance to your common text. This needs to be agreed during your DCP/MRP.
  7. Have you generated mock-ups?  We recommend generating your mock-ups early in the process so they are available for submission at the national phase. Doing so prevents the need for submission of Article 61 (3) at a later date.
  8. Do you have someone who can complete national documents in a timely manner?  Source local consultant’s in each market where you don’t a presence. Each EU country has different national phase requirements. Knowing what they are and having someone you can rely on to complete national documents efficiently is vital to obtaining national license schedules in a timely fashion.
  9. Do you understand what each local health authority requirement is and do you need separate national authorisation numbers (i.e. The PZN in Germany)?
  10. Have you identified distributors?  Identify your local distributors early in the procedure. Some countries require that these companies are registered on your local license and appear on your artwork.

We Can Help

Making sure that you and your team have addressed the 10 questions listed above can speed up processes and remove impediments that might slow down progress in getting your product to market.  We help clients all over the world with issues like this on a daily basis and we can help you too.  Talk to us today by calling us on 00353 52 61 76 706 or complete your details below and we will get back to you and start helping you to get your product to market.

Further Reading from Acorn Regulatory

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Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about it here.  5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated.

Read the full article here.

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance, and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.

Download the e-book here.

A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail.

Read more here.