The importance of Module 1

Module 1 of a dossier is a critical component when registering and maintaining your products in global markets and must comply with local regulations and legislation. Module 1 of the dossier houses the administrative data of the applicant, product information, and additional declarations and annexes.

How PLG compiles documents for Module 1

We can guide, prepare, and compile this information for all markets and dossier types.

The information is prepared in collaboration with our local experts, and the relevant information from Modules 2 through 5.

We can translate the documents into the target market’s local language using our internal translation team if required.

Documents contained in Module 1

  • Cover letter
  • Application forms
  • Product information
  • Information about the experts
  • Specific requirements for different types of applications
  • Environmental risk assessment(s)
  • Information relating to orphan market exclusivity
  • Information relating to pharmacovigilance
  • Information relating to clinical trials
  • Information relating to pediatrics
  • Responses to questions
  • Annexes
  • Declarations

The advantages of using PLG to support the compilation of your Module 1

Module 1 compilation requires market-specific knowledge and can be time-consuming, involving inputs from various stakeholders. We can support your team to ensure the accurate and timely completion of Module 1 to meet your submission timelines.

We have gained experience from compiling thousands of Module 1 documents for numerous health authorities globally, meaning you can trust that your submission and –  significantly – your products are in the safest hands.

KEY FIGURES :

1000+

Average annual volume of Module 1 compiled

100+

Markets where we have compiled Module 1