Regulatory Labelling

Regulatory Labelling guidelines are there to ensure medicinal compliance, for the safe and effective of medicinal products used by patients. These labelling regulations can vary from region to region with new regulations routinely introduced to update labelling documents.

The core safety and clinical information about a medicinal product is shared with the healthcare professional and patients often in the form of a regional/local labels such as Summaries of Product Characteristics (SmPC) for EU; Product Monograph (PM) in Canada; United States Prescribing Information (USPI) in the US. However, a Company Core Data Sheet (CCDS) is known as the company’s global position and this is a document that is used to craft labelling worldwide.

Guidance mandates and recommendations are issued for each different aspect of labelling, such as clinical labelling, dosage and administration, warnings and precautions, adverse reactions and general guidance with respect to therapeutic group classes. This makes global and regional labelling management a complex and time-consuming activity for life sciences companies to ensure consistency and compliance across the concerned regions

How can we support?

RApport provides an end-to-end regulatory labelling services to help pharmaceutical companies build and maintain labelling information, including safety and efficacy information on country-specific labels to enable compliance and due diligence in their labelling for their drug product portfolio.

Our highly skilled labelling Subject Matter Experts (SME) provide initial labelling assessment to determine your needs and to help you understand labelling regulations. Our panel of experts can handle complex tasks, such as creating, updating and maintaining the Company Core Data Sheets (CCDS), Additionally, we can provide hands-on guidance on regional specific regulation changes such as the (Pregnancy Lactation Labelling Rule) for the US FDA; the Falsified Medicines Directive that affects all EU markets to incorporate track and trace serialisation coding on outer-packages for the EU, as well as the BREXIT impact analysis that will affect labelling as well as artwork.