Years of experience

Successfully registered products

Satisfied customers

Services

Consulting

We help our clients to formulate and develop their companies´ strategic goals. In this regard, we contribute with our multiple years of experience in all areas of the pharmaceutical business.

MARKET RESEARCH

One of our main driving forces is the focus on the specifics of the western balkans' market. Our experienced team maintains constant communication with pharmacies and physicians of all specialties, keeps up with the latest therapeutic protocols in different branches of medicine, analyzes data from all available sources and decides which new products, both medicines and food supplements, should be promoted through everyday activities on the market via medical representatives.

DISTRIBUTORS

Our experienced team can offer you a wide range of distributors in order to find the one which fits your business philosophy best, your products’ marketing and your products’ access to the market. Successful entrance and the best promotion on the local market are guaranteed.

PRICING OF THE PRODUCTS

Our team will help you set appropriate prices for Serbian market for different ranges of products:

» medicines

» pharmaceutical cosmetics

» dietary supplements

It includes:

» competition analysis

» marketing strategy

» following legislative rules set by relevant Authorities

MARKETING & SALES

We offer marketing solutions adapted to the local markets, while preserving the original identity of our products and implementing the key brand values and messages. Successful marketing of a pharmaceutical product greatly depends on a good marketing plan. We offer you the plan and much more than that. The objective of our marketing team is that you, our partner, become successful in this dynamic, competitive and demanding business environment. That is why we provide the best solutions in implementing your business strategy.

Within the scope of our marketing services, we can - fully or in part - look after your products:

» market analysis

» marketing plan development

» product launches 

» launch management + promotional material

» event management

» PR

Exclusive Represention

Do you wish to enter the Serbian pharmaceutical market as soon as possible?

If yes, AB OVO is your answer. 

AB OVO offers its international partners – pharmaceutical manufacturers worldwide, first-class full servicing. We save a lot of precious time and resources for representatives who want to offer their products to the local consumers. With our extensive experience on the regional pharmaceutical market, we ensure rapid and stable sales results for our partners.

EXCLUSIVE REPRESENTATION INCLUDES:

    » Product registration according to the requirements of all local legislation;

    » Marketing Authorization Holder (MAH);

    » Pre-wholesale;

    » Marketing and communication to all target groups on the pharmaceutical market – doctors, pharmacies and end-customers.

 

Regulatory Affairs

Marketing Authorization Holder (MAH)

AB OVO can represent you in front of the Authorities and become Marketing Authorisation Holder of your products as well as lawyer and bookkeeping services. This would allow you to reduce your costs related to: firm opening, staff employment, rental costs, lawyer and bookkeeping services.

ACCORDING TO THE LAW ON MEDICINES AND MEDICAL DEVICES:

Article 27

Following entities shall file the application for a marketing authorisation to the Agency:

1) A medicinal product manufacturer who is licensed to manufacture medicinal products in the Republic of Serbia;

2) Agent or representatives of foreign manufacturers based in the Republic of Serbia; 

3) Representative of a foreign legal entity that is not the medicinal product manufacturer, but the marketing authorisation holder in the European Union member states or in countries that have the same requirements for the issuance of a marketing authorisation for a medicinal product based in the Republic of Serbia; 

4) Legal entity based in the Republic of Serbia onto which the manufacturer, referred to in Item 1) of this Paragraph, transferred the marketing authorisation, or to whom it gave the right to acquire the properties of a marketing authorisation holder for medicinal products from its production line; Applicant for a marketing authorisation under Paragraph 1 of this Article (hereinafter referred to as: the applicant) must have a person responsible for pharmacovigilance, as well as a person responsible for documentation in the process of obtaining the marketing authorisation, its variations and renewals, with whom it concluded a full-time employment contract for the indefinite period of time.

Persons referred to in Paragraph 2 of this Article must be graduates from the Faculty of Medicine, Dentistry or Pharmacy, or the Faculty of Veterinary Medicine for veterinary medicinal products. In addition to the conditions specified in Paragraph 2 of this Article, the applicants referred to in Paragraph 1, Items 3) and 4) of this Article shall have the person responsible for batch release that meets the requirements of this Law and regulations adopted to implement this Law.

Applicant shall be responsible for documentation in the procedure of obtaining a marketing authorisation.

MEDICINES

MARKETING AUTHORISATION PROCEDURE

» Regulation of the applicant’s legal status 

» Preparation & Submission of dossiers to the ALIMS* 

» Follow-up procedures & Communication with the ALIMS representatives 

» Text & Document translation 

» Text formatting 

» Creating packaging mock-ups 

» Readability testing & Score

LIVECYCLE MANAGEMENT

» MA extensions 

» MA Variations & Renewals 

» Reviewing of the promotional materials 

» Labelling & Packaging

PHARMACOECONOMICS

» Medicinal product pricing & Reimbursement 

*Medicines and Medical Devices Agency of Serbia

MEDICAL DEVICES

» Registration of business entities at the ALIMS* 

» Application forms 

» Text translations & Revision 

» Professional reviewing of promotional materials 

» Preparation of promotional materials 

» MD labelling 

» MD vigilance *Medicines and Medical Devices Agency of Serbia

FOOD SUPPLEMENTS

» Food business operators (FBO) & Status regulation 

» Preparation & Submission of dossiers to the Authorities 

  -Pharmaceutical Faculty in Belgrade, in charge of product categorization 

  -Referent laboratory in charge of products’ content analysis (“Dr Milan Jovanovic Batut” Institute of Public Health of Serbia) 

  -Ministry of Health, responsible for entering products into the Database 

» Text translations & Revision 

» Professional reviewing of promotional materials 

» Preparation of promotional materials

Partners

Epsilon Health Medicals

4, Palama K. Str., 543 52 Pilea, Thessaloniki, Greece

Derma Sciences

Suite 4, Unit A1 Tectonic Place, Holyport Road, Maidenhead, Berkshire, SL6 2YE, United Kingdom

NTC s.r.l.

Via Luigi Razza3, 20124 Milan, Italy

PIETRASANTA PHARMA Spa

Via di Caprino, 7, 55012 Capannori, Italy

Gruppo Farmaimpresa s.r.l.

Via Cipro n. 1, 25124 Brescia, Italija

OFM, LLC

Build. 18, Suschevskiy Val str., Moscow, 127018, Russia

Nirial Pharma Srl

Via Lorenzo Mascheroni 27/29, 20145, Milano, Italy

Laboratoires INELDEA

ZI de Carros 10ème Rue – 4ème Avenue, 06510 Carros, France

Frequently asked questions

Silben nano repair - faq

  • Silben nano repair has a wide range of indications. These are: scratches, tears, cuts, first and second degree burns, ulcer, decubitus/initial degree/, diabetic foot, dermatitis, ulcers, postoperative wounds, varicella superinfections, wetting wounds and code insertion of central, venous and arterial catheters.
    Silben nano is recommended to be an integral part of every home and travel pharmacy.

  • The spray is completely safe for children from the first year of life.

  • The wound should be cleaned with saline or any disinfectant before applying the spray. Silben nano repair neither interacts nor reacts with any means for disinfection.

  • Before each application of the spray, clean the wound and apply the spray to a dry area twice a day. Before spraying, it is necessary to shake the bottle. Even when applied once a day, the area is safe for 24 hours until the next dressing, if any the same on a daily basis.

  • There is no limit to the period of use of the spray. If the spray is used for a long time, it is advised to protect the skin around the wound with medical cream Medihoney - Protective cream or some care cream.

  • If they are superficial wounds, it is not necessary, but in the case of large, deep or postoperative wounds always bandage the wound after cleaning the wound and applying the spray.

  • There are no contraindications, unless there is sensitivity to one of the ingredients or if the product is used before the first year of life.

  • The results are excellent especially with wounds that moisturize, because the spray has kaolin in its composition which has the role of adsorbent.

  • Once opened, the spray is stored at room temperature and the expiration date is stamped on the bottom packaging. There is no shortening of the shelf life after the start of use.

Medihoney® - faq

  • No, MEDIHONEY® is Medical Grade Honey. Medical grade means the honey has been filtered to a higher level than food grade honey, and has been sterilised.
    MEDIHONEY® is made from Active Leptospermum Scoparium (= Manuka) honey, which is indigenous to New Zealand. Manuka Honey offers effective non-resistant antibacterial action and is the only species of honey shown in randomised controlled studies to help wounds progress towards healing.

  • Scientists have now discovered one of the principal (and measurable) components responsible for the active antibacterial action of MEDIHONEY® is Methylglyoxal (otherwise known as MGO). The level needed to be active is = >355mg/Kg, and the MGO level in MEDIHONEY® is = >355mgs/Kg.

  • Bees contribute an enzyme called glucose oxidase to honey. Glucose oxidase is converted to gluconic acid and hydrogen peroxide in the wound. However, upon interaction with catalase (an enzyme present in wound fluid/blood/tissue) hydrogen peroxide breaks down into water and oxygen. .
    The Antibacterial mode of action of MEDIHONEY® is NOT due to this process, but as a result of other factors (MGO being one of them), the antibacterial effect is not destroyed by catalase therefore is not due to hydrogen peroxide = Non-Peroxide Activity

  • The different compounds and physical properties in MEDIHONEY® work synergistically to both kill bacteria and assist wound healing. This is why we do not single out one particular active component of the honey. There are altogether 5 modes of action of MEDIHONEY®, including:


    • Antibacterial
    • Debridement
    • Malodour neutralisation
    • Immune stimulation
    • Anti inflammatory
  • MEDIHONEY® has shown positive performance on a variety of wound types and aetiologies from the start of the wound through to wound closure including:

    • Leg ulcers, various aetiologies incl. Venous, Arterial, Diabetic Foot
    • Donor sites
    • Oncologic wounds
    • Pressure ulcers (I-IV)
    • Traumatic and surgical wounds
    • 1st and 2nd degree burns
  • MEDIHONEY® Antibacterial Medical Honey is 100%, with honey consistency, i.e can be liquid. MEDIHONEY® Antibacterial Wound Gel is thickened with a safe natural product to make it more viscous and thus does not ‘run’.

  • Yes. It has been proven not to interact with the level of glucose in the blood and thus totally safe to use on all wounds on Diabetics. It is however, always recommended with Diabetics to continuously monitor blood glucose levels..

  • MEDIHONEY® is used prior to, during and after Negative Pressure Wound Therapy (NPWT) with tremendous success.

  • Yes. MEDIHONEY® dressings can be left in place under compression and off-loading devices.

  • Allergy to honey, in this instance it is recommended not to be used. Due to the low pH, some patients may notice transient stinging, even pain. If stinging does not stop or persists, a clear protocol for analgesia needs to be followed.

  • All MEDIHONEY® dressings can be worn for up to 7 days, depending on the level of exudate and should be reapplied when the secondary dressing has reached its absorbent capacity or as directed by a wound care professional.

Contact

Our Adress

Kostolačka 79, 11010 Voždovac, Belgrade, Serbia