Is Your Product Labeling Style Guide Up to Date? 2022 EMA Updates You Should Know
Bringing medicinal products to the market is a slow and intricate process.
Aside from exhaustive clinical research, planning, and thorough regulatory reviews, life sciences companies need to stay up to date with the latest guidelines governing these procedures.
This post highlights the key changes in the Quality Review of Documents (QRD) guidelines used by the European Medicines Agency (EMA).
What Are the EMA Guidelines?
The EMA guidelines ensure the use of safe and accurate language in pharmaceutical product labels and package leaflets. It defines QRD decisions on stylistic issues like abbreviations, foreign terms, gender, and the acceptable use of “invented” names.
In June 2022, the EMA made significant changes and additions to these guidelines.
1. The word “drug” in product annexes
Issue: Can the word “drug” be used in product annexes?
According to the latest EMA guidelines, the word “drug” should be avoided in product information annexes.
In certain regions, the word “drug” is often associated with illegal drugs (e.g., narcotics). It’s subject to mistranslation, misinterpretation, and misrepresentation, which could potentially diminish the quality of the product’s documentation and cause confusion among patients and even healthcare professionals.
However, “drug” can still be used in general phrases or terms.
Some examples are:
- Drug interaction
- Drug elimination
- Adverse drug reaction
2. Direct speech in the Summary of Product Characteristics (SmPC)
Issue: What writing style is acceptable in product package leaflets and SmPCs?
Package Leaflets are lawfully required to use active voice instead of passive voice for clarity and readability.
For example, instead of writing, “Consider returning the product if the seal is broken,” write “Return the product if the seal is broken.”
For SmPC, passive voice is preferred because these documents are intended for different audiences and not just patients. Active voice, however, is still required for specific information like dosage recommendation tables and instructions on storage, handling, and disposal.
3. Multilingual information on Annex IIIA
Issue: How to include Annex IIIA text that may be accepted in multilingual packs?
If the company (applicant) and the EMA conclude that shortened terms/abbreviations can be used in multilingual labels, these can be added following the proper translated English term. These multilingual terms must use gray shading for visibility.
For instance, the Dutch version of a multilingual pack may include the abbreviation “I.V.” next to the translation of the word “Intravenous Use.” The abbreviation must be shaded with the color gray.
4. Changes regarding INN translation
Issue: How to include common International Non-proprietary Names (INN) if it’s included in the product’s name?
Some medicines use INNs in their product names, which could potentially cause confusion among native speakers of a language in which the INN is common.
The EMA guidelines outline how INNs must be presented in the SmPC of various languages.
In the 2022 update, the EMA added more specific examples for BE languages (FR, DE, and NL).
For BE language translations concerning INNs, the English term isn’t allowed if it’s very different from any of these national languages.
INNs like Ibuprofen can be used since their translations across all national BE languages are similar. If the INN is vastly different between the BE languages, all variations must be included in the SmPC.
5. Number separators between languages
Issue: How to use number separators in multilingual product information annexes?
Multilingual product information annexes should follow the number separator format used in the relevant Member State of the European Union.
- EN (English), MT (Maltese): Decimals use a dot (1.5 mg)
- Other languages: Decimals use a comma (1,5 mg)
Separators for large numbers (thousands, millions, etc.)
- EL (Greek), IS (Icelandic), NL (Dutch): Separators should use dots (1.000 mg)
- BG (Bulgarian), CS (Czech), DE (German), DK (Danish), EN (English), ES (Spanish), FI (Finnish), FR (French), IT (Italian), LT (Lithuanian), LV (Latvian), MT (Maltese), NO (Norwegian), PL (Polish), RO (Romanian), SK (Slovak), SV (Swedish): Space (1 000 mg)
- ET (Estonian), HU (Hungarian), HR (Croatian), PT (Portuguese), SL (Slovenian): No space for four-digit numbers, space for large numbers with five digits or more (1000 mg / 10 000 mg).
The guidelines for multilingual number separators may differ in certain cases. This, however, must be approved by all relevant authorities, as per the applicant’s request.
6. Unit dose pack sizes for DE and MT
Issue: How “unit dose” must be used in the SmPC, package leaflet, and outer carton.
The number of tablets or capsules in a perforated blister must be stated using specific formats for the outer carton, package leaflet, and SmPC.
In the latest EMA guidelines update, the translations of “perforated unit dose blisters” for the DE and MT languages are added.
7. International standard base unit for liter (EL, EN, and MT)
Issue: Should the unit for liter be represented with an “l” or “L?”
The EMA guidelines allow liter (unit of measurement) to be indicated with either an uppercase “L” or a lowercase “l,” depending on the relevant member state.
New requirements are introduced in the 2022 update for the EL, EN, and MT languages. For these languages, either “l” or “L” can be used, except if the unit is preceded by the number “1,” in which case, the uppercase “L” must be used.
8. English or Latin translations of INNs in product information annexes
Issue: How should multilingual labeling be presented with space constraints?
The use of English or Latin is allowed by some Member States of the European Union to keep multilingual labels readable with space constraints. When needed, this nullifies the requirement of including label information for all relevant Member States.
The EMA recently updated this guideline, specifically for the CS (Czech) language, to allow the use of either English or Latin.
Update Your Product Documentation With EMA Compliance in Mind
Welocalize leverages state-of-the-art quality control systems that ensure compliance with the latest EMA guidelines. Check our localization guide “How to Build a Localization Program” to learn which step in the process of establishing and updating a localization style guide is performed and how it affects the product quality.
Welocalize Life Sciences has extensive experience working with regulatory agencies around the globe, including the FDA, AEMPS, ANSM, PMDA, and EMA (including centralized and decentralized procedures, Quality Review of Documents working group, local authority templates, and the application of EDQM and MedDRA glossaries.) Our language professionals work within a framework of regulated processes and robust quality-control systems that mitigate risk to provide translations and ensure your products reach the market faster.