Taña Dalglish Nov 23, 2013:

Muriel and fvasconcellos I did see "over-labelling" but hesitated (pharmaceuticals/medical is not my strength) LOL!
Over Labelling Service | Pharmaceutical Companies UK | Kent ...
www.kentpharm.co.uk/Kent_Pharmaceutical/file/over-labelling...‎
Kent Pharmaceuticals is one of the leading UK pharmaceutical companies and can offer an efficient and **cost effective over labelling service.** Fvasconcellos - go ahead and put in your proposed answer! Regards to all.

Muriel Vasconcellos (asker) Nov 23, 2013:

@ fvasconcellos Hi Filippe,
I knew you'd know! Do you want to propose an answer?

Filippe Vasconcellos de Freitas Guimarães Nov 23, 2013:

Hi, Muriel! Both the FDA and the UK MHRA use the very direct term "over-labeling". (I presume "sobre-etiquetado" is a calque.)

Relabeling and Over-labeling
Over-labeling by placing a new label over an old label is discouraged by FDA but is acceptable as long as the new label and its use meet GMP requirements for attachment, legibility, reprocessing, and change control. (Over-labeling is also discouraged in some foreign countries.)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...

Over labelling
"We have discovered an error on the printed packaging for a specific batch of one of our products. Could you please confirm if it is permitted to over label the primary packs with the most up to date approved labelling?"

All information on packaging (both primary and secondary) for any licensed medicinal product must be printed directly on to the relevant packaging element. It is not acceptable to present any information by means of an over label.
http://www.mhra.gov.uk/Howweregulate/Medicines/Labelspatient...

lorenab23 Nov 23, 2013:

@ Muriel I know your text is from Central America, but I found something from Peru (now I can't find the link) that seems to suggest that sobre-etiquetada means that a new label was placed over the old one.

Muriel Vasconcellos (asker) Nov 23, 2013:

Further clarification It would seem that the outer label is not supposed to be there. Do you agree? Later, the document says: "sin embargo, en cuanto al sobre-etiquetado, en vista de la fecha estimada de culminación de nuestro proyecto en curso de etiquetado directo en español, tenemos a bien solicitar la aceptación de la muestra de renovación y para comercialización **con sobre-etiquetado** con nuestro compromiso de que una vez culminado dicho proyecto, poder comercializar el producto xxx **sin el sobre-etiquetado**