To harmonize specifications for identification and description of medicinal products internationally, a set of five EN/ISO international standards have been introduced. Identification of Medicinal Products (IDMP) provides base standards for identifying medicinal products uniquely to ensure smooth functioning of Regulatory operations such as development, registration and life cycle management of medicinal products; pharmacovigilance and risk management. The purpose of IDMP standards is to allow exchange of medicinal product information in a consistent and robust manner.
- EN ISO 11238 (Substance Identification) – This standard defines substances based on the general, main and specified characteristics. It also allows the specification of substances which have multiple components.
- EN ISO 11239 (Dosage Identification) – Identifies and defines standards for pharmaceutical dosage forms, routes of administration, packaging etc.
- EN ISO 11615 (Medicinal Product Identification [MPID]) – This standard clearly defines and identifies medicinal products for human use.
- EN ISO 11240 (Units of Measurement) – Identifies and defines specific rules for the usage of measurement units.
- EN ISO 11616 (Pharmaceutical Product Identification [PhPID]) – Uniquely identifies a generic medicinal product at various elemental level.
If implemented as intended, the IDMP is beneficial for:
- Pharmacovigilance – Unique identification of medicinal products help in improving the pharmacovigilance drastically. Harmonized definition of products also improves the quality of data sets used in the safety signals, globally.
- Submissions – With IDMP standards, the data related to the medicinal products can be communicated easily amongst companies and Regulatory bodies.
- Clinical Trials – Set standards help investigators to improve assessments and evaluations of the medicines.
- Good Manufacturing Practice (GMP) – Manufacturing site inspections have become streamlined as the site data is more accessible and is available in a defined format.
Though there have been many speculations about IDMP and its implementation timeframes, it is always advisable that medicinal product owners be prepared for it for successful compliance. Streamline your preparations. To know more about IMDP and how it be prepared, reach out to Freyr at email@example.com.