Artworks
As part of the approval process of a new medicine, medical device, food supplement or cosmetic product, there is a requirement to prepare a carton box, label, patient leaflet and/or physician leaflet according to the Israeli Ministry of Health procedures.
Following the approval and marketing of the medicine, occasionally there is a need to change or update the information printed on the artwork.
Registration holders of products belonging to the above mentioned groups are required to comply with many requirements determined by the regulator that refer to the content of the information and its placing, design (such as font size, colors), warnings, translation to other languages and more.
Blau Pharmaceutical Services has great experience in preparing artworks and proposes extensive services of preparing the text, professional translation to the languages: Hebrew, English, Arabic, Russian, graphic design and printing.
We work under a proven quality management system, ISO 9001:2008 IS, in order to provide you with a product that complies with the standards required by the Ministry of Health, international pharmaceutical and medical device companies, Israeli manufacturers and importers representing manufacturers around the world.
We are proud of the positive results of the quality audits conducted at Blau Pharmaceutical Services by our customers, and of the ongoing improvement in work performance and quality.
Artwork requirements of importers and manufacturers of medicines, medical devices, cosmetics and food supplements
The Ministry of Health requires importers/manufacturers (registration holders) to market medicines, medical devices, cosmetics and food supplements with artworks printed according to regulations and procedures such as:
a. Procedure 43 – Labeling of packaging materials of a medicinal product {Pharmacy department}
b. Guidelines for labeling medical devices {Medical device department}
c. Guidelines for labeling regular and dedicated cosmetics
d. Third supplement to the public health regulations (food) labeling of food supplements
The main points that should be taken in consideration before launching new products and during marketing, due to variations in their registration conditions (the license) are as follows:
- Information printed on some of the artworks should appear in a number of languages, and actually up to 4 languages on medicine carton boxes and in GSL medicinal leaflets (certificate of free sale): Hebrew – English- Arabic- Russian.
- Precise medical translation of different languages
– Font size and type
– Marking certain information in different colors such as: different dosages of the same medicine - Special signs such as: Cytotoxic, Prescription only medicine, OTC, etc.
- Special warnings such as: amount of sodium, lactose, vitamin, mineral
- The technical specifications required by the sites in which the packaging takes place or printing presses
- The software required for the graphic design
- The current health authority requirements
- Uniform information on all of the artworks of a product
- Prevention of spelling and punctuation mistakes
- High resolution of the text, especially the illustrations
- Working according to internal procedures that comply with the Ministry of Health requirements in order to prevent bias of the medical staff and harm to the patients
Our Services in the artworks field
It is important to us that the final product that you receive will comply with the highest criteria, whether it is the Israeli, USA, European, Canadian, Australian, New Zealand or Japanese health authorities or whether it’s your own requirements or your associates requirements. We do not believe in shortcutsleading to compromise in quality. As a result, the services you receive are given by a staff that has undergone substantial training and certification, a large, experienced and professional staff that is well aware of the heavy responsibility that rests on their shoulders.
Blau Pharmaceutical Services understands the importance of complying with agreed upon schedulesand operates an advanced project management system for achieving this goal.
We are proud of working with many customers and preparing them the following, amongst other projects.
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Preparation of artworks and publications services include:
- Precise medical / pharmaceutical translation to Hebrew- English- Arabic- Russian, and if required also back translation.
- Graphic design (including graphic layout, addition of barcode and pharma code) in all software according to the customer’s request.
- Printing of leaflets (including folding), booklets, labels and/or carton boxes in offset technology or digital printing up to 8 pantone colors.
- Performing the above mentioned activities according to the Ministry of Health requirements and the customer specifications.
- Quality control during the process in order to ensure a high quality product to the customer’s satisfaction.
- Analysis of anomalies and drawing conclusions (CAPA)
- Constant improvement in performance due to customer feedback.
Production of artworks may be “expensive” (for example following recall from the market or destruction of printed artworks) and damage your company’s image as of high quality and successful. Therefore there is no substitute for receiving this service from a well experienced company, that has dealt with complex challenges over the last 10 years. There is no doubt, that the product of our work today, expressed in the quality of the work and work schedule, is significantly higher than it was 5 or 7 years ago, when we were “new” in the artworks field.
Performing projects of producing artworks is a privilege for us and your gain!
Join our loyal customers, because we care!