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eSubscription in Europe and US

eSubscription is the process of registering medicinal products for marketing authorisation at the local authorities.

eSubscription requires in current regulations in the US and Europe substantially different technologies, terminologies and vocabularies for registration of medicinal products. In the US, the FDA requires a “Structured Product Labeling” (SPL). In Europe, the European Medical Agency (EMA) initiated a new standard called IDentification of Medicinal Products (IDMP). It is most likely that FDA will take-over these standards in near future. IDMP raised the bar significantly by requiring information be sent in specific form for each country and language and coded with an ISO Code.

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Lot Distribution Report LDR

Lot Distribution Report LDR

In US under 21 CFR 600.81, marketing authorisation applicants must submit to the Center for Drug Evaluation and Research (CDER), LDRs containing certain specified information every 6 months about the quantity of the product distributed under their Therapeutic Biologic Applications (BLAs).

Biologic Lot Distribution Data must be submitted in SPL XML format within eCTD submissions.

FDA requires applicants to submit Biologic LDRs in an electronic format that the agency can process, review, and archive. This reporting requirement is effective as of June 10, 2015.

Every six months, applicants must submit to the appropriate center, LDRs containing certain specified information about the quantity of the product distributed under their BLAs (including to distributors).

The lot distribution file should be included in eCTD Module 3, section 3.2.R Regional Information. The lifecycle for this file should be updated as appropriate, in accordance with the current eCTD specification.

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SPL

The FDA requires a “Stuctured Product Labeling” (SPL) for the registration of medicinal products.

UNII Substances
Unique Ingredient Identifier – a non-proprietary, free, unique, unambiguous, nonsemantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. The substances are to be coded by a UNII code.

Country Codes
SPL represents countries with ISO 3166-1 Alpha-3 country codes

SPL – Drug Route of Administration Terminology
Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.
SPL Pharmaceutical Dosage Form Terminology
Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the Structured Product Labeling documents.

SPL Package Type Terminology
Terminology used for representation of the information on pharmaceutical product package type in the framework of the Structured Product Labeling documents.

SPL Unit of Presentation Terminology
Terminology that encompasses dosage form, package type, and unit of measurement (aka potency) terms used in supporting regulatory submissions in electronic format such as drug establishment registration and drug listing.

SPL Unit of Measure Terminology
Terminology that represents units of measure in supporting regulatory submissions in electronic format such as drug establishment registration and drug listing.

Download SPL Controlled Vocabularies from IDMP1:

SPL´s data are actualised by the FDA regularly. Please license our service download SPL Controlled Vocabularies to get noticed the moment the terms and the download files are actualised and to download the actual files.