
Communication of dispensing drugs and narcotic substances in offices and pharmacy units
The pharmacies and the pharmacy units in health centers must communicate annually the movements of medicines and narcotic substances from January 1 to 31 of the following year.
Notice: Communication of dispensing medicines for hospital use and in clinical packaging
Notice
- Medications for hospital use and in clinical packagingAs of 23/12/2022, pharmacies do not have to communicate the dispensing of qualified medicines for hospital use and in clinical packaging.
- ObligationThey must have supporting documentation of their dispensation at the disposal of the General Directorate of Inspection and Sanitary Regulation for 5 years.
Notice
Communication of dispensing drugs and narcotic substances in offices and pharmacy units
Requirements to carry out the communication
The owner owners or, where appropriate, regents of the pharmacy office and those responsible for the pharmacy units in health centers, as of December 31 of the year object of the annual communication, must:
- Submit the annual communication from January 1 to 31 of the following year, through the Labofar application of the Spanish Agency for Medicines and Health Products.
- Have a username and password to access the application, which will be provided by the General Directorate of Health Inspection and Regulation.
how it communicates
Communication is done through the app labofar of the Spanish Agency for Medicines and Health Products.
At the AEMPS website, pharmacies and pharmacy units in health centers will be able to access the application, the manual for the presentation of notifications and the data of the emails to which they should direct any questions that may arise in relation to notifications.
See the List of narcotic substances and medicines below, as well as the instructions in the notification manual.
In the event that there are discrepancies with the ending stock declared in the previous year the application will not allow you to continue the declaration.
If the declaration corresponds to a Pharmacy office You should contact the Official College of Pharmacists of Madrid, where they will inform you of the steps to follow.
In the case of corresponding to a pharmacy unit in health center should be addressed to the email estupefacientes@salud.madrid.org with the communication of the incident, attaching a document signed by the person in charge of the pharmacy unit justifying the causes for the discrepancies with the declaration made in 2021 and the completion of the excel file "Discrepancies".
- Labofar Guide to notifications of narcotic drug movements
- Notification discrepancies in the stock of narcotic drugs
- List of narcotic substances and medicines
Regulation
- Law 13/2022, of December 21, on Management and Pharmaceutical Care of the Community of Madrid (BOCM No. 304, of December 22).
- Royal Decree 1675/2012, of December 14, which regulates official prescriptions and the special requirements for prescription and dispensing of narcotic drugs for human and veterinary use (BOE No. 313, of December 29).
- Royal Decree 717/2019, of December 5, which modifies Royal Decree 1345/2007, of October 11, which regulates the procedure for authorization, registration and dispensing conditions of manufactured medicines for human use industrially (BOE nº 293, of December 6).
Contact Us
Authorization Area for Centers, Services and Pharmaceutical Establishments
C/ Customs, 29 - 4th floor - 28013 Madrid
Telephones: 91 426 90 19 / 91 426 92 83