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

Medihoney® - faq

• Is MEDIHONEY® made with regular honey?

  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.

• What is MGO?

  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.

• What is meant by Non-Peroxide Activity (NPA) of honey?

  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

• What are the properties in MEDIHONEY® that make it effective for wounds and burns?

  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
• What are the most commons usages of MEDIHONEY® dressings?

  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
• What is the difference between MEDIHONEY® Medical Honey and MEDIHONEY® Wound Gel?

  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’.

• Can MEDIHONEY® be used in and on Diabetics?

  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..

• Can MEDIHONEY® be used along with Negative Pressure devices?

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

• Can MEDIHONEY® be used under compression for 7-days??

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

• What are the precautions?

  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.

• How often should the dressings be changed?

  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.