1

Version 3.0 December. 2012.

Recommendations for the translationsof the Product Information submitted to the National Institute for Quality- and Organizational Development in Healthcare and Medicines

Directorate General of National Institute of Pharmacy

(Summary of Product Characteristics, Package Leaflet, Labelling)

National Institute for Quality- and Organizational Development in Healthcare and Medicines

Directorate General of National Institute of Pharmacy

Quality Review of Product Information Department

  1. Recommendations for the translators of Product Information by EMA

On the website of the EMA (European Medicines Agency) ( the Regulatory/Human medicines / Product information section summarizes the recommendations regarding the content, layout and background materials (QRD template and appendices). Being up-to-date and having extensive/professional knowledge about these are essential for the required high quality translation.

We suggest that you exclusively cooperate with qualified translators or translation agencies that have detailed knowledge of the above mentioned documents, and are able to apply them at the highest possible level.

It is advisable to make sure in advance that the translators are in possession of such fundamentals.

Only those Product Information are approved by our Institute that meet the formal and content requirements of EMA, particularly the official Hungarian translation of the current QRD Product Information template.

To differ from this is only possible in exceptional cases, for example if the English Product Information, which served as a basis for the translation, was created in a previous template version.

2. The evaluation method for Product Information translations in the National Institute for Quality- and Organizational Development in Healthcare and Medicines

Directorate General of National Institute of Pharmacy

The linguistic quality of the translated Product Information is controlled by the Quality Review of Product Information Department.

The Quality Review of Product Information Department –with the help of the professional assessment work of joint departments— is concerned with the linguistic quality and professional correctness of the translations from the point of view of the translation – while taking the protocols and recommendations of the EMA QRD into consideration.

The guideline of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) „Best practice guide for decentralised and mutual recognition procedures” (last time updated in April 2012)also states that the translation to the national language should be the highest possible quality.

The guideline is available here:

Ifthe problems related to the translations are highlyserious and the quality of the translation is unacceptable, the Institute will request the Applicant to submit new HUPI (Hungarian Product Information).In this case the 30 days national phase is restarted from the new HUPI’s arrival to the Institute.

The Quality Review of Product Information Department doesnot accept such Product Information that containsgrammatical, translation or text interpretation errorsthat can result in a serious risk to public health.

Incomplete translationsand texts,thatwere automatically taken from other Hungarian Product Information, and are not equal to the English Product Information, will not be approved by the Institute.

The Product Information (further referred to as PI) assessor will mark corrections with trackchanges, then the document will be returned to the Applicant by e-mail, requesting the review of texts and correction of the mistakes with trackchanges. Applicants have 5 business days to review the Product Information and respond via e-mail to the assessor. With the returned response is taken into account, the PI will be finalized.

Should there be no feedback within 5 business days, the PI will be finalized based on the information available.

  1. Qualitative aspects regarding the translations of the Hungarian Product Information
  • Formal aspects

On the website of the working group of EMA QRD, the current QRD template versions can be found in English and in Hungarian, with and without trackchanges.Separately for Centralised,and separately for Mutual Recognition /Decentralised/Referral and National procedures.

Concerning the font type and font size, word spacing, line spacing, etc., the recommendations of the ”QRD convention to be followed for the EMA-QRD templates” should be applied.

  • Linguistic, grammatical aspects

Compliance with the word order, grammatical and spelling rules of the Hungarian language is essential.See also: „A magyar helyesírás szabályai – Akadémiai Kiadó”.

The spelling of terms and nomenclatures should be standardized (e.g.: in the SmPC hypertonia or „hipertónia”, and oedema or „ödéma” is acceptable but within one document the dual spelling is not acceptable.

However, in the Package Leaflet of the same medicinal productin case of eg. ‘hypertonia’ the phonetically spelt version should appear (ie. “hipertónia”) – if at all is necessary, but preferably the patient friendly form “magas vérnyomás” should be used.

In case of terms and nomenclatures it is expedient to use the Latin spelling, but it should be weighed how entirely (or partly) the given word or term has transferred to the Hungarian terminology with Hungarian spelling. (eg.: ödémásodás, szívinfarktus, miokardiális infarktus, indikáció, kapilláris, mikroflóra, baktérium, vírus, kreatinin-clearance).

In case of Hungarian and other foreign language compound words (Latin, English, etc.) the spelling shouldnot be mixed (eg.: tüdőödéma and not tüdő-oedema or tüdőoedema).

See also: „Orvosi helyesírási szótár –Akadémiai Kiadó”

The Applicants are requested to use the Hungarian phonetic spelling in case of names of active substances in each and every Product Information (eg.: nátrium-klorid, biszakodil, eritromicin, klórpromazin, rozuvasztatin).

Absolute adherence to the English text is an essential aspect in the translation.

(The translator should keep in mind whether in the course of retranslating the translated text would mean exactly the same as the original.)

Regarding to adherence it should be taken into account whether the foreign-language terminology has a Hungarian medical/pharmaceutical term (not necessarily in Hungarian), commonly used in Hungarian terminology (for Example: ulcerative colitis – colitis ulcerosa, but never ulceratív colitis!). However, in the course of translating the Package Leaflets it is essentialto ensure the intelligibility for laymen as well. (Eg.: ulcerative colitis – fekélyes vastagbélgyulladás as explained earlier).

In case of widely used Latin or other foreign language terms in the Hungarian terminology, forcing the translation should be avoided (eg.: anatomical terms). In many cases there are several acceptable translations.

When the term is given first and the explanation after in brackets in the foreign language Package Leaflets, the Applicants are requested to give them in reverse order in the Hungarian translation.