Translation of pharmaceutical documentation: leaflets, SmPC, registration dossier and certificates of analysis

A pharmaceutical document serves two completely different readers: the regulator, who takes the decision on registering the medicine, and the patient, who takes the leaflet out of the box brought home from the pharmacy and tries to understand how to take the medicine. In both cases a translation error directly concerns safety: an incorrectly carried over contraindication, an omitted interaction or an ambiguously worded dosage causes real harm. We translate the full range of pharmaceutical documentation for importers, distributors, manufacturers and contract laboratories, in compliance with the requirements of the Georgian regulator and the standards of international pharmaceutical terminology.

What documents are involved

Pharmaceutical documentation falls into three large groups, and each has its own language and reader:

Registration and regulatory documents

• the summary of product characteristics (SmPC), intended for doctors and pharmacists
• the patient information leaflet (PIL) and the package leaflet placed in the box
• the registration dossier in CTD format, especially Module 1 and Module 2 (summaries)
• the marketing authorisation, the certificate of a pharmaceutical product (CPP) and the free sale certificate
• variation and renewal applications, correspondence with the regulator

Quality and manufacturing documents

• the certificate of analysis (CoA) per batch, with analytical methods and specifications
• the GMP certificate and the manufacturing licence
• stability study reports, validation protocols
• safety data sheets (SDS/MSDS) for active substances
• batch manufacturing records, release certificates

Labelling and commercial documents

• primary and secondary packaging labels, carton text
• pharmacovigilance documents: PSUR, risk management plan, safety notifications
• marketing and scientific materials for doctors, tender technical specifications

SmPC and package leaflet: one medicine, two languages

The SmPC and the patient leaflet contain the same information about the same medicine, but in completely different language. The SmPC says "monitoring of transaminases is recommended because of the risk of hepatotoxicity", while the patient leaflet says "this medicine may damage your liver, so your doctor will order blood tests from time to time". Both wordings are medically exact, but each fits its reader.

We translate the SmPC in the structure of the European QRD template (sections 4.1 indications, 4.2 posology, 4.3 contraindications, 4.4 special warnings, 4.5 interactions, 4.8 undesirable effects and so on), because the Georgian regulator and doctors rely on exactly this structure. The patient leaflet is given a readability test: an editor without a medical education reads the text and marks every place where a misunderstanding could arise.

Terminology: where the risk hides

• The name of the active substance: we use the international nonproprietary name (INN) in the established form of Georgian transliteration, not a free adaptation. "Amoxicillin" is always written the same one way in Georgian, never in a variant spelling.
• Pharmaceutical form and dosage units: "film-coated tablet" and "coated tablet" are different forms; "mg/ml", "international unit" and "mcg" must never be mixed up.
• Frequency of undesirable effects: MedDRA terminology and the frequency categories ("very common", "common", "uncommon", "rare", "very rare") are carried over with their standard equivalents.
• Pharmacokinetics: bioavailability, half-life, volume of distribution and clearance must be translated as established in the Georgian pharmacological literature.
• Storage conditions: "Do not store above 25 °C" and "Store in a refrigerator (2 °C to 8 °C)" must be carried over to the label exactly and in the standard wording.

Certificate of analysis and analytical documentation

The certificate of analysis (CoA) is a table in which the specification, the analytical method and the result obtained are given for each parameter. Here the translation preserves two things: pharmacopoeia references (Ph. Eur., USP, BP, JP) in unchanged form, and the names of analytical methods (HPLC, GC, dissolution test, microbiological purity) with their established Georgian equivalents. Numbers, units and acceptance limits are carried over identically to the original and checked line by line by a second specialist, because a CoA translation is often submitted to customs, a tender or a regulator's inspection.

Regulatory requirements in Georgia

For registration of a medicine in Georgia the regulatory agency requires a Georgian-language SmPC, patient leaflet and label artwork. Under the recognition procedure (when the medicine is already registered in a country with a stringent regulator) part of the documents is accepted in English, but the patient-facing text is always required in Georgian. We know which document is required in which format and prepare the package so that the submission goes through without remarks. Where needed we certify the translation with the agency's seal or notarize it.

Label and packaging text

Label translation is a separate discipline, because the text must fit into a limited area and match the graphic artwork. We translate so that the Georgian text, which is usually longer than the English, fits into the fields of the artwork, while the mandatory elements (name, dose, form, batch, expiry date, storage conditions, "keep out of the reach of children") are in the standard wording. We check the artwork together with the designer, so that the text is proofread before printing.

Who contacts us

• importers and distributors of medicines who need a full Georgian-language package for registration
• foreign manufacturers and their representative offices in Georgia
• Georgian manufacturers preparing an English-language dossier for export
• contract research organisations and sponsors of clinical trials who need the documentation of the investigational product for submission to an ethics committee
• pharmacy chains and hospitals drawing up tender technical specifications

For a regular client we create a terminology base in which the names of medicines, pharmaceutical forms and standard phrases are agreed once and then used identically in every document. This is especially important for an importer with a portfolio whose documentation for dozens of medicines is updated regularly.

Frequently asked questions