Quality Policy
Nomeco’s quality policy is designed to ensure the integrity of medicines while they are in Nomeco’s custody.
Nomeco is responsible for maintaining traceability and preventing counterfeit medicines from entering the legal supply chain.
All employees at Nomeco are familiar with our quality policy.
It is a shared responsibility to comply with the rules. We believe that “Quality is doing the right thing – even when no one is watching.”
- We must ensure that the quality of medicines is not compromised during storage and distribution.
- We must deliver the right medicine, on time, to the right recipient.
Good distribution and manufacturing practices
We always work in accordance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP), which are laid down in Danish legislation. In addition, we are certified according to the ISO 9001 standard.
Quality management
All work processes at Nomeco are carefully described in instructions, and our employees receive continuous training in how to perform their tasks. The instructions are administered through our Quality Management System (QMS), which ensures that we always work according to updated and approved guidelines.
Quality is a shared responsibility and all employees are expected to live up to both the GDP rules and the specifications set out in our instructions.
Inspections and audits
The Danish Medicines Agency inspects us regularly to ensure that we comply with applicable regulations and have full control over safety, documentation, storage facilities, handling, etc. In addition, pharmaceutical companies also conduct regular audits to ensure that their products are handled in accordance with applicable standards.
Product recall
In Denmark, the Danish Medicines Agency must be contacted first in connection with a recall of a medicine from the market. Nomeco recommends the following for recalls:
1. Contact the Danish Medicines Agency
Agree with the Danish Medicines Agency what needs to be done. If necessary, remember to agree with the Danish Medicines Agency how to contact your customers (e.g. pharmacies, hospitals or wholesalers). You can contact the Danish Medicines Agency on +45 4488 9595.
2. Contact Nomeco
If you are a supplier to Nomeco Wholesale: Send an email to purchase@nomeco.dk or call your daily contact person in our purchasing department.
If you are a supplier to Nomeco HealthCare Logistics: Contact your daily contact person in HealthCare Logistics customer service by phone and email indkoeb@nomeco.dk AND send an email to purchase@nomeco.dk.
Outside normal business hours, Nomeco can be contacted on +45 3645 4536, where an on-call centre will take your call. However, if you contact us by phone, we must receive written confirmation of the cancellation instructions within one hour via the above email addresses.
We will immediately block the recalled item and handle the goods as agreed with the supplier. We will also be ready to receive recalled goods back from the market (e.g. pharmacies, hospitals and others).
Recall from the pharmacy according to the agreement with the Danish Medicines Agency
A recall of medicinal products must (cf. §33 on Complaints and recalls in the Danish Executive order on distribution of medicinal products) be possible immediately and at any time. If you, as a manufacturer or importer, need to withdraw a medicinal product from private pharmacies, you can contact us at purchase@nomeco.dk. For contact information for private pharmacies, we refer to the Danish Pharmacists Association.
You are encouraged to immediately send the recall to the country's pharmacies from your own email. We recommend that you always send the email to all pharmacies, as you can never be completely sure who has the medicine in question.
Authorisations and certificates
GDP authorisation / Authorisation for wholesale distribution of medicinal products
The GDP authorisation is issued by the Danish Medicines Agency under §39 of the Danish Medicines Act. It authorises Nomeco to wholesale pharmaceuticals and to supply drug samples directly to doctors, veterinarians and dentists under contract. Download the GMP licence here.
GMP authorisation / Authorisation to manufacture and import medicinal products and intermediates
The GMP authorisation is issued by the Danish Medicines Agency under §39 of the Danish Medicines Act. It authorises Nomeco to manufacture human and veterinary medicinal products. Download the GMP licence here.
Nomeco places great emphasis on delivering high quality and has therefore also chosen to be certified according to the ISO 9001 standard. Together with the Danish Medicines Agency's authorisations, this is your guarantee that Nomeco documents quality management from start to finish and thus always delivers consistent quality in accordance with the agreements made. Download Nomeco's ISO 9001 certificate here
Import control
Denmark has implemented Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Article 51 of the directive describes what is required for medicinal products to be freely distributed across EU borders.
Certificate of inspection
When supplying medicinal products from other EU/EEA countries, the delivery must be accompanied by a certificate of inspection (§24 of the GDP regulation).
A certificate of inspection is defined as a ‘certificate signed by the qualified person [...] stating that the medicinal product, including intermediate products and active substances, has been manufactured in accordance with good manufacturing practice and meets the requirements on which the marketing authorisation is based.’
In order to accept a document as a certificate of inspection, Nomeco must be able to see the following explicitly:
- The medicinal product and intermediates and active substances must be manufactured according to GMP
- Medicines comply with the marketing authorisation. It is important to mention the marketing authorisation explicitly and to state which market the marketing authorisation applies to (country(ies) or all of Europe for centralised marketing authorisations)
- A signature of a QP located in the EU or an EEA country
The rule on certificates of inspection applies to all medicinal products brought into Denmark from EU/EEA countries. Medicines that are not covered by a marketing authorisation, such as non-registered specialities and clinical trial medicines, must also be import controlled - not against a certificate of inspection, but a similar document.
Packaging master control
If the medicine is not accompanied by a certificate of inspection or if the medicine arrives from a non-EU/EEA country, the medicine must be released by a QP within the EU/EEA before sale or further distribution can take place. This is described in the GMP regulation.
In connection with the supplier's release, Nomeco can check the received medicines against a packaging master.
The Danish Medicines Agency prefers that import controls for deliveries between EU countries are carried out against certificate of inspection, but there may be circumstances that prevent this.
