Mock-ups checklist - Guidance for checking mock-ups

Transcription

1 24 March 2014 EMA/102667/2014 Veterinary Medicines Division Mock-ups checklist - Guidance for checking mock-ups This guidance should be read in conjunction with: the guideline on the packaging information of veterinary medicinal s authorised by the Community in Volume 6C as published on the Commission website the Quality Review of Documents veterinary -information annotated template (English) - clean (currently in use template) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal s as amended Please note that all elements on the approved information (PI) attached to the CVMP opinion should be taken into account when preparing mock-ups. The checks mentioned in this guidance are standard checks and instructions but it remains the approved PI which prevails. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0) Facsimile +44 (0) info@ema.europa.eu Website An agency of the European Union

2 READABILITY A. OUTER/IMMEDIATE PACKAGE Comments Critical labelling elements (Invented) name of the veterinary medicinal Strength (if applicable) Pharmaceutical form (only shown on outer pack (Art 58.2)) Active substance(s) Package size(only shown on outer pack (Art 58.2)) Target species Withdrawal period (if applicable) Method and route of administration Indications (if space allows and only where mentioned in the approved PI) Special warnings, if necessary Expression of expiry date, including necessary space for putting appropriate data Special storage conditions, if applicable Special precautions for the disposal of unused s or waste materials, if any The words For animal treatment only and conditions or restrictions regarding supply and use, if applicable Name and address of the MAH Marketing authorisation number Expression of manufacturing batch number, including necessary space for putting appropriate date The words Keep out of the sight and reach of children Nothing obviously promotional. A discreet logo of the MAH can be used. The elements mentioned in bold should be prominent on the packaging, e.g. in larger font size, and it is recommended to mention them on the front of the packaging. This requirement is optional for multilingual packs. Name of the The name should be stated as per the SPC. See example: Vet 0.5 mg tablets for dogs. Format of the name can differ from the format used in the PI. Page 2/8

3 Print size, quality and type Minimum 8 pt. The text should be easily readable (print type, size and space between lines) for the healthcare professionals, farmers or animal owners. The (invented) name of the (e.g. Vet) may be larger than the rest of the text. The rest of the name (e.g. 0.5 mg tablets for dogs) should be located next to or under the (invented) name and can be displayed in a smaller font size. Print colour Distinguishable colours from the background for print of characters should be used. Use of background colour should not adversely impact on readability of the text. Do not use green on red or red on green, as these pose problems for people who are colour blind. Blue-box Please check that the blue-box is present if applicable. Local representative names and/or contact details to be mentioned only if stated in the package leaflet AND in the approved PI. A discreet logo of the local representative is allowed in the blue-box. A blue-box is permitted on the immediate label where there is no outer package. Pictograms/Logo A pictogram in addition to the text is allowed if it is of an informative/educational nature, e.g. for route of administration or species for which the presentation is intended. It is recommended in the case of pictograms displaying animal species, that when feasible, the pictogram be in accordance with the intended presentation (e.g. symbols showing a large dog or a small dog). Pictures / photos of the target species are also allowed on the labelling but should not impact readability of the text. Layout of text Multilingual packs should be clearly legible and, where practical, grouping of text elements for each language is recommended. The use of language abbreviation may also be used to distinguish grouped languages. Page 3/8

4 Barcode A barcode is allowed on the labelling. QR (Quick response) code The applicant/mah should contact the Agency for further information. B. SMALL IMMEDIATE PACKAGING UNITS Comments Critical labelling elements (Invented) name of the veterinary medicinal Strength (if applicable) Pharmaceutical form (only shown on outer pack (Art 58.2)) Quantity of the active substance (if not already included in the name) Package size (only shown on outer pack (Art 58.2) Target species (if not already included in the name) pictogram to be used on a case-by-case basis to replace mentioning the target species) Withdrawal period (if applicable) Route(s) of administration Total content/volume/dose (where relevant) Expression of manufacturing batch number (Batch/Lot) (according to country requirements), including necessary space for putting appropriate data Expression of expiry date (EXP) (according to country requirements), including necessary space for putting appropriate date The words For animal treatment only Nothing obviously promotional. A discreet logo of the MAH can be used. The bold elements to be in larger font size, where feasible. Name of the The name should be stated as per the SPC See example: Vet 0.5 mg tablets for dogs. Format of the name can differ from the format used in the PI. Page 4/8

5 Print size, quality and type Minimum 8 pt. With regard to multi-lingual packaging and very small bottles/vial sizes, e.g. 2 or 10 ml, 8 pt. is in most cases not achievable, but the closest font size should be sought. The text should be easily readable (print type, size and space between lines) for the healthcare professionals, farmers or animal owners. The (invented) name of should be larger than the remainder of the text where feasible. Print colour Distinguishable colours from the background for print of characters should be used. Use of background colour should not adversely impact on readability of the text. Do not use green on red or red on green, as these pose problems for people who are colour blind. Layout of text Multilingual packs should be clearly legible and where practical, grouping of text elements for each language may be done. Blue-box No blue-box should be present, unless specific national requirements are required. Barcode A barcode is allowed on the labelling. QR (Quick response) code The applicant/mah should contact the Agency for further information. Page 5/8

6 C. BLISTER OR STRIP Comments Critical labelling elements (Invented) name of the veterinary medicinal Strength (if applicable) Pharmaceutical form only shown on outer pack (Art 58.2) Active substance(s) Target species (if not already included in the name; clear pictogram might be used on a case by case basis to replace mentioning the target species) Full or abbreviated name of the MAH Expression of expiry date (EXP) (according to country requirements), including necessary space for putting appropriate data Expression of manufacturing batch number (Batch/Lot)(according to country requirements), including necessary space for putting appropriate date The words For animal treatment only. Nothing obviously promotional. A logo of the MAH can be used. A clear pictogram of the target species might be used to replace mentioning the target species. Print size, quality and type Minimum 8 pt. With regard to multi-lingual blisters, 8 pt is in most cases not achievable, but the closest font size should be sought. The text should be easily readable (print type, size and space between lines) for the healthcare professionals, farmers or animal owners. The (invented) name of the (e.g. Vet) should be larger than the rest of the text. Print colour Distinguishable colours from the background for print of characters should be used. Layout of text Where practical, the name and strength of the should appear over each blister pocket. Often it will not be possible to apply all the information over each blister pocket, consequently where a random display of the information is proposed it should frequently appear across the pack. In all cases it will be acceptable to apply the batch number and expiry date to the end of the blister or strip. For blisters with an individual pocket for a single dose, all text must appear on each pocket. Multilingual packs should be clearly legible and where practical, grouping of text elements for each language may be done. Blue-box No blue-box should be present. Page 6/8

7 Barcode / QR (Quick response) code Barcode / QR codes are not allowed on the blister or strip. Only identification barcodes used for identification purpose on the packaging line are allowed. D. PACKAGE LEAFLET Comments Critical elements Nothing obviously promotional. A logo of the MAH can be used. It is advisable that all elements should follow the order of Annex III.B of the current QRD template and the approved package leaflet. Name of the The name should be stated as per the SPC; See example: Vet 0.5 mg tablets for dogs. In case of multilingual package leaflets the information above should appear at the beginning of each language. The use of language abbreviations may also be used to distinguish multilingual package leaflets. Print size, quality and type Minimum 8 pt. The text should be easily readable (print type, size and space between lines) for the healthcare professionals, farmers or animal owners. The readability should be acceptable e.g. font size, layout and paper quality. The pictures explaining the use of the medicinal should be clearly printed. Print colour Distinguishable colours from the background for print of characters should be used. Page 7/8

8 Local representatives Listing of local representatives is not a requirement, but if included in the information annexes, the full list for all Member States must be stated. However, a representative may be designated for more than one country and may also be the MAH where no other local representative is indicated. In cases where the same representative is designated for more than one country, the representative s details may be listed only once below the names of the countries concerned. In the printed package leaflet, only the concerned local representative can be mentioned provided the whole list has been included in the information annexes. Blue-box No blue-box is required. QR (Quick response) code The applicant/mah should contact the Agency for further information. Page 8/8